Alpelisib Plus Fulvestrant for PIK3CA-Mutated Advanced Breast Cancer: Final Survival Results from the SOLAR-1 Trial Explained for Patients

Table of Contents

• Key Points
• Understanding the Basics: What This Study Is About
• Why This Research Matters
• How the Study Was Conducted
• Key Findings: Survival Results
• Who Benefited Most: Subgroup Analyses
• Secondary Endpoints: Delaying Chemotherapy and Next Treatments
• Safety and Side Effects
• What This Means for Patients
• Study Limitations
• Recommendations for Patients
• Frequently Asked Questions
• Source Information

Key Points

• In the SOLAR-1 trial, alpelisib plus fulvestrant improved median overall survival to 39.3 months versus 31.4 months with placebo in PIK3CA-mutated advanced breast cancer.
• The 7.9-month survival gain did not reach the trial's strict statistical significance threshold, but it was consistent with a significant progression-free survival benefit.
• Alpelisib delayed the need for chemotherapy by a statistically significant 8.5 months: median time to chemotherapy was 23.3 months versus 14.8 months.
• Patients with lung or liver metastases showed a 14.4-month longer median overall survival with alpelisib, though this subgroup analysis was based on small numbers.
• Side effects like rash and hyperglycemia were manageable, and only 3% discontinued alpelisib due to adverse events during extended follow-up.

Understanding the Basics: What This Study Is About

Breast cancer is not a single disease, but a collection of different conditions with distinct characteristics. This study focuses on a specific type of advanced breast cancer defined by three features: hormone receptor-positive (HR+), HER2-negative (HER2−), and the presence of a mutation in a gene called PIK3CA.

Hormone receptor-positive (HR+) means the cancer cells have receptors that bind to estrogen and/or progesterone, which can fuel cancer growth. HER2-negative means the cancer does not have excess amounts of the human epidermal growth factor receptor 2 protein on its surface. Together, HR+/HER2− advanced breast cancer is the most common subtype of breast cancer.

The PIK3CA gene provides instructions for making a protein called p110α, which is a subunit of an enzyme known as phosphatidylinositol-3-kinase (PI3K). This enzyme plays a critical role in cell growth, division, and survival. When PIK3CA is mutated, the PI3K pathway becomes overactive, driving uncontrolled cancer growth.

PIK3CA mutations are found in 28% to 46% of people with HR+, HER2− advanced breast cancer, according to data from multiple studies cited in this article. These mutations are not just common; they are clinically significant. Research has shown they are associated with chemoresistance, meaning the cancer is less likely to respond to chemotherapy, and with a worse overall prognosis.

One study cited in this paper, the SAFIR-02 trial, found that patients with PIK3CA mutations had a median overall survival of 19.6 months, compared with 23.5 months for patients without the mutation. This nearly 4-month difference highlights the urgent need for targeted treatments specifically designed for this high-risk population.

Why This Research Matters

For years, the standard approach to treating HR+/HER2− advanced breast cancer has involved endocrine (hormone) therapy, often combined with other agents. However, when the cancer stops responding to aromatase inhibitors (AIs)—a class of hormone therapy—treatment options become more limited, and the prognosis worsens, particularly for patients with PIK3CA mutations.

Alpelisib (brand name Piqray) is an orally administered, α-selective PI3K inhibitor—a targeted therapy designed to block the overactive PI3K pathway driven by PIK3CA mutations. According to the study, alpelisib is 50 times more potent against the α isoform of PI3K than against other isoforms, making it a highly specific therapy. In laboratory models, alpelisib has shown a dual mechanism of action: it inhibits PI3K activity and also induces the degradation of the p110α protein in a dose-dependent manner.

Earlier results from this same trial, called SOLAR-1, were practice-changing. The primary analysis demonstrated that adding alpelisib to fulvestrant—a medication that blocks and degrades the estrogen receptor—significantly improved progression-free survival (PFS), which is the time a patient lives without the cancer growing. The median PFS was 11.0 months with alpelisib plus fulvestrant versus 5.7 months with placebo plus fulvestrant (hazard ratio [HR] = 0.65; 95% CI, 0.50–0.85; P = 0.00065). The overall response rate (meaning the percentage of patients whose tumors shrank or disappeared) was 26.6% versus 12.8%.

However, at the time of that initial report, the overall survival data were not yet mature. This paper presents the final, preplanned analysis of overall survival after more than three years of follow-up—the definitive answer to whether the survival benefit matches the progression-free survival benefit.

How the Study Was Conducted

Trial Design and Participants

SOLAR-1 was a global, phase 3, prospective, randomized, double-blind, placebo-controlled trial. The study enrolled postmenopausal women and men with confirmed estrogen receptor-positive and/or progesterone receptor-positive, HER2− advanced breast cancer whose disease had progressed while on or after treatment with an aromatase inhibitor. Patients were not allowed to have received prior chemotherapy for advanced disease.

A total of 572 patients were enrolled and divided into two cohorts based on whether a PIK3CA mutation was detected in tumor tissue: the PIK3CA-mutant cohort and the non-mutant cohort.

In the PIK3CA-mutant cohort, 341 patients were randomized in a 1:1 ratio to receive either:

• Alpelisib plus fulvestrant: 169 patients received 300 mg of alpelisib taken orally once daily, combined with 500 mg of fulvestrant given by intramuscular injection
• Placebo plus fulvestrant: 172 patients received a placebo pill plus the same fulvestrant regimen

Fulvestrant was administered on days 1 and 15 of the first 28-day cycle, and then on day 1 of every subsequent 28-day cycle. The dosing schedule allowed for minor adjustments of ±3 days.

In the non-mutant cohort, 231 patients were randomized similarly (115 to alpelisib plus fulvestrant and 116 to placebo plus fulvestrant). Importantly, treatment crossover from placebo to alpelisib was not permitted at any point during the study.

Patients were stratified (grouped) by two factors: the presence of lung or liver metastases and prior treatment with CDK4/6 inhibitors (a class of targeted therapy commonly used in HR+ breast cancer).

Eligibility for the mutant cohort required at least one of 11 specific PIK3CA mutations to be detected in tumor tissue. Dose reductions were permitted in the event of severe or intolerable adverse reactions—up to two dose reductions were allowed, though only one was permitted for pancreatitis, after which the patient was discontinued from the study drug.

Endpoints (What the Researchers Measured)

The primary endpoint of the SOLAR-1 trial was investigator-assessed progression-free survival in the PIK3CA-mutant cohort, which had already been reported. The key secondary endpoint, reported in this paper, was overall survival (OS) in the PIK3CA-mutant cohort—the time from randomization until death from any cause.

The final inferential analysis of OS was prespecified to occur after approximately 178 deaths were documented. The study was designed with 72% power to detect a true hazard ratio of 0.67, which corresponds to an improvement in median survival from 30 months (expected in the placebo group) to 45 months (expected in the alpelisib group) at a one-sided 2.0% level of significance.

For the results to be considered statistically significant, the P-value needed to be ≤ 0.0161, based on an O'Brien-Fleming spending function—a strict statistical boundary designed to control for the possibility of false-positive results while allowing for interim looks at the data.

Exploratory endpoints included progression-free survival 2 (PFS2), defined as the time from randomization to disease progression on the first new systemic cancer therapy given after stopping study treatment, or death from any cause. The researchers also performed a post hoc (after-the-fact) exploratory analysis of time to chemotherapy (TTC), measuring the time from randomization to the first administration of chemotherapy following discontinuation of study treatment.

Additional Analyses

An exploratory survival analysis was also conducted in patients whose PIK3CA mutation was detected in plasma circulating tumor DNA (ctDNA)—a liquid biopsy approach that looks for tumor DNA in the blood—regardless of whether they were assigned to the mutant or non-mutant cohort based on tissue testing. This allowed the researchers to validate the tissue-based mutation testing approach against a less invasive blood-based method.

Key Findings: Survival Results

Patient Disposition: Who Stayed on Treatment Longer

The data cutoff date for this final analysis was April 23, 2020. The median follow-up from randomization was 42.4 months (range: 33.1–55.7 months)—meaning the average patient was tracked for more than three and a half years.

One striking finding was the difference in how long patients remained on treatment. At the time of data cutoff:

• 21 patients (12.4%) in the alpelisib plus fulvestrant arm were still receiving study treatment
• Only 7 patients (4.1%) in the placebo plus fulvestrant arm were still receiving study treatment

This means three times as many patients were still benefiting from alpelisib-based therapy after more than three years—a meaningful indicator considering these patients had PIK3CA-mutated disease, which is associated with a poor prognosis.

The most common reason for discontinuing treatment was disease progression, which occurred in 65.7% of patients in the alpelisib arm versus 80.2% in the placebo arm. Only 3.0% (5 patients) discontinued due to side effects in the alpelisib arm, compared with 1.7% (3 patients) in the placebo arm.

Overall Survival: The Main Result

At the time of this analysis, a total of 181 deaths had occurred: 87 events (51.5% of patients) in the alpelisib plus fulvestrant arm and 94 events (54.7%) in the placebo plus fulvestrant arm. The median follow-up for overall survival was 30.8 months (range: 0.4–53.4 months).

The headline result was:

• Median overall survival: 39.3 months (95% CI, 34.1–44.9) with alpelisib plus fulvestrant
• Median overall survival: 31.4 months (95% CI, 26.8–41.3) with placebo plus fulvestrant
• This represents a 7.9-month numerical improvement in median overall survival
• Hazard ratio = 0.86 (95% CI, 0.64–1.15; one-sided P = 0.15)

The prespecified O'Brien-Fleming efficacy boundary of P ≤ 0.0161 was not crossed. This means that while the survival difference favored the alpelisib group, the result did not meet the very strict threshold for statistical significance set by the study design. The authors note this was expected given the study was not powered to detect an effect as small as the one observed.

For context, a hazard ratio of 0.86 means that patients in the alpelisib group had a 14% lower risk of death at any given time point compared with the placebo group. The wide confidence interval (0.64–1.15) indicates substantial uncertainty around this estimate—the true effect could range from a 36% reduction in risk to a 15% increase in risk.

Despite not crossing the statistical boundary, the clinical picture is consistent with the earlier progression-free survival benefit. The authors emphasize that these results "further support the statistically significant prolongation of PFS observed with alpelisib plus fulvestrant in this population."

Survival in Patients with Detectable Mutation in Blood (ctDNA)

Among patients whose PIK3CA mutation was detected in plasma circulating tumor DNA (a subgroup that included some patients classified as non-mutant by tissue testing), the survival benefit appeared even more pronounced:

• Median overall survival: 34.4 months (95% CI, 28.7–44.9) with alpelisib plus fulvestrant
• Median overall survival: 25.2 months (95% CI, 20.7–29.6) with placebo plus fulvestrant
• Hazard ratio = 0.74 (95% CI, 0.51–1.08)

This represents a 9.2-month improvement in median survival for patients whose mutation was detectable in blood, with a hazard ratio suggesting a 26% reduction in the risk of death.

Who Benefited Most: Subgroup Analyses

The researchers examined overall survival across multiple patient subgroups defined by clinical characteristics. While some of these subgroups were small, making conclusions less reliable, several patterns emerged.

Patients with Lung and/or Liver Metastases

Visceral metastases (spread to the lung or liver) are associated with a more aggressive disease course and worse outcomes. The analysis showed that this subgroup derived particular benefit from alpelisib:

• Median overall survival: 37.2 months (95% CI, 28.7–43.6) with alpelisib plus fulvestrant
• Median overall survival: 22.8 months (95% CI, 19.0–26.8) with placebo plus fulvestrant
• Hazard ratio = 0.68 (95% CI, 0.46–1.00)

This 14.4-month improvement in median survival is clinically substantial. The hazard ratio of 0.68 indicates a 32% reduction in the risk of death, and the upper boundary of the confidence interval (1.00) just touches the line of no effect, suggesting a borderline but potentially meaningful benefit.

Other Subgroup Findings

The full breakdown of subgroup analyses revealed variable results:

• Patients without lung/liver metastases: HR = 1.18 (95% CI, 0.74–1.86)—no benefit observed in this group
• Patients with bone-only disease: HR = 1.74 (95% CI, 0.83–3.68)—no benefit observed, though this group was small (77 patients)
• Patients without bone-only disease: HR = 0.76 (95% CI, 0.55–1.06)
• Patients with prior CDK4/6 inhibitor treatment: HR = 0.67 (95% CI, 0.21–2.18)—suggested benefit, but only 20 patients in this subgroup
• Patients without prior CDK4/6 inhibitor treatment: HR = 0.87 (95% CI, 0.64–1.18)
• Estrogen receptor-positive patients: HR = 0.86 (95% CI, 0.64–1.16)
• Progesterone receptor-positive patients: HR = 0.78 (95% CI, 0.55–1.11)
• Progesterone receptor-negative patients: HR = 1.07 (95% CI, 0.58–1.99)
• Patients receiving study treatment as first-line therapy: HR = 0.78 (95% CI, 0.51–1.19)
• Patients receiving study treatment as second-line therapy: HR = 0.93 (95% CI, 0.61–1.43)
• Patients with primary endocrine resistance (cancer progressed within 2 years of starting hormone therapy): HR = 0.62 (95% CI, 0.29–1.35)
• Patients with secondary endocrine resistance (cancer progressed after 2 years of hormone therapy): HR = 0.92 (95% CI, 0.65–1.29)
• Patients with sensitive disease to endocrine therapy: HR = 0.82 (95% CI, 0.22–3.14)
• Patients with ECOG performance status 0 (fully active): HR = 0.86 (95% CI, 0.59–1.27)
• Patients with ECOG performance status 1 (restricted but ambulatory): HR = 0.77 (95% CI, 0.47–1.23)

The authors caution that several subgroups had small numbers of patients, and the results should be interpreted with care. However, the consistent trend toward benefit in patients with lung/liver metastases, PgR-positive tumors, and those without bone-only disease suggests that specific clinical profiles may predict greater response to alpelisib.

Secondary Endpoints: Delaying Chemotherapy and Next Treatments

What Happened After Patients Stopped Study Treatment

A total of 148 patients in the alpelisib arm and 164 patients in the placebo arm discontinued study treatment. Among these patients, 78.4% (116 patients) in the alpelisib arm and 81.7% (134 patients) in the placebo arm initiated a subsequent cancer therapy.

The types of subsequent treatments received were illuminating:

• Chemotherapy-based regimens (including chemotherapy plus hormone therapy) were the most common subsequent treatment in both arms, received by 50.0% of alpelisib patients and 56.0% of placebo patients
• Hormone therapy-based regimens (including combinations with targeted therapy) were initiated by 49.1% of alpelisib patients and 41.8% of placebo patients
• Targeted therapy alone or with hormone therapy was used in 32.8% (38 patients) of alpelisib patients versus 27.6% (37 patients) of placebo patients
• CDK4/6 inhibitors were used in similar proportions: 11.5% (17 patients) in the alpelisib arm versus 13.4% (22 patients) in the placebo arm
• Everolimus was used in 17.2% (20 patients) versus 15.7% (21 patients), respectively

The fact that fewer patients in the alpelisib arm needed subsequent chemotherapy—and that those who did received it later—suggests the combination provided durable disease control.

Progression-Free Survival on Next Therapy (PFS2)

PFS2 measures the total disease control from randomization through the first subsequent therapy—essentially capturing the benefit of the initial treatment plus the effect of delaying the need for the next line of treatment. By data cutoff, 118 patients (69.8%) in the alpelisib arm and 126 patients (73.3%) in the placebo arm had progressed on next therapy or died.

Median PFS2 was:

• 22.8 months (95% CI, 18.5–26.3) with alpelisib plus fulvestrant
• 18.2 months (95% CI, 12.8–22.2) with placebo plus fulvestrant
• Hazard ratio = 0.80 (95% CI, 0.62–1.03)

This 4.6-month improvement in PFS2 corresponds to a 20% reduction in the risk of progression or death on subsequent therapy.

Time to Chemotherapy (TTC)

One of the most clinically meaningful findings was the delay in the need for chemotherapy. In this post hoc analysis:

• 95 patients (56.2%) in the alpelisib arm received their first chemotherapy for metastatic disease
• 109 patients (63.4%) in the placebo arm received their first chemotherapy
• Median time to chemotherapy: 23.3 months (95% CI, 15.2–28.4) with alpelisib plus fulvestrant versus 14.8 months (95% CI, 10.5–22.6) with placebo plus fulvestrant
• Hazard ratio = 0.72 (95% CI, 0.54–0.95)

Patients in the alpelisib arm went an average of 8.5 months longer before needing chemotherapy, a statistically significant difference (the confidence interval does not include 1.0). For many patients, delaying chemotherapy is a meaningful quality-of-life benefit, as chemotherapy often comes with more challenging side effects than targeted therapy.

Safety and Side Effects

Safety monitoring continued throughout the extended follow-up period, and the results were reassuring. No new safety signals were observed with longer exposure to alpelisib, and no cumulative (worsening-over-time) toxicity was noted for any adverse event.

The most notable side effect profile:

• Rash (a group of related skin reactions including rash, maculo-papular rash, dermatitis, and related conditions) occurred in 54% of patients in the alpelisib plus fulvestrant arm versus 9% in the placebo plus fulvestrant arm
• However, most rash events were low grade (grade 1 or grade 2), meaning they were manageable with monitoring and supportive care
• Hyperglycemia (elevated blood sugar), a known side effect of PI3K inhibitors, did not increase in frequency with longer time on treatment

Side effects were described as generally manageable with close monitoring, administration of additional medications to manage symptoms, and dose modifications when needed. Discontinuation rates due to adverse events were low in both groups: 3.0% in the alpelisib arm and 1.7% in the placebo arm.

Given the timing of the study, the researchers also reported that there were no cases of confirmed or suspected COVID-19 infection and no COVID-19-related deaths among the study participants.

What This Means for Patients

The SOLAR-1 trial provides important, though nuanced, evidence about the long-term benefits of alpelisib in PIK3CA-mutated advanced breast cancer. Several key messages emerge for patients and their oncologists:

First, the numeric survival improvement is real and meaningful. The 7.9-month improvement in median overall survival, while not meeting the strict statistical threshold, aligns with the previously demonstrated highly significant progression-free survival benefit. The hazard ratio of 0.86 suggests a 14% reduction in the risk of death, and in certain subgroups—particularly patients with lung or liver metastases—the benefit was considerably larger.

Second, the delay in chemotherapy is a significant patient-centered benefit. The statistically significant 8.5-month extension in time to chemotherapy (23.3 months versus 14.8 months, HR = 0.72, P < 0.05) means patients spent more than 8 additional months on a well-tolerated oral targeted therapy before needing intravenous chemotherapy. This finding reached statistical significance and represents a concrete quality-of-life advantage.

Third, the PIK3CA mutation matters for treatment selection. Evidence from earlier analyses of SOLAR-1 demonstrated that the benefit of alpelisib was specific to patients with PIK3CA mutations—the proof-of-concept criteria were not met in the non-mutant cohort, confirming that PIK3CA is a predictive biomarker. This means genetic testing of the tumor (and potentially blood) is essential to identify which patients are most likely to benefit from alpelisib.

Fourth, longer follow-up confirms the durability of benefit. The fact that 12.4% of patients in the alpelisib arm remained on treatment after 42 months of follow-up—versus just 4.1% in the placebo arm—suggests that a meaningful subset of patients experiences long-term disease control. Given that PIK3CA-mutated disease is associated with a worse prognosis (19.6 months versus 23.5 months in the SAFIR-02 study), any durable benefit is clinically valuable.

Finally, the safety profile is acceptable for a chronic therapy. The manageable side effect profile, low discontinuation rates due to adverse events, and absence of cumulative toxicity support the use of alpelisib as a long-term treatment option. Rash and hyperglycemia require monitoring but are generally controllable with standard measures.

Study Limitations

Like all clinical trials, SOLAR-1 has limitations that patients and clinicians should understand when interpreting these results:

• The overall survival analysis did not cross the prespecified statistical significance boundary. The study was designed to detect a 15-month improvement in median survival (from 30 to 45 months), which was more optimistic than the 7.9-month improvement actually observed. The study had only 72% power to detect this larger effect, meaning it was underpowered to detect smaller, still meaningful, survival differences as statistically significant.
• Crossover was not permitted, which can bias results in either direction. In some trials, patients in the placebo group are allowed to switch to the experimental treatment after progression. While the lack of crossover here means the observed effect was not diluted, it also means the survival data reflect a pure comparison of initial treatment strategies.
• The subgroup analyses included small numbers of patients. Several subgroups (e.g., patients with prior CDK4/6 inhibitor treatment, n = 20; patients with primary endocrine resistance, n = 45) were too small to draw definitive conclusions. The apparent lack of benefit in some subgroups (e.g., bone-only disease) could reflect true biology or simply statistical noise.
• The study population was mostly postmenopausal women. Only a small number of men were included, and the results may not fully generalize to premenopausal women or to men with this disease.
• Patients with prior chemotherapy for advanced disease were excluded. The results apply to patients earlier in their treatment course, not those who have already received chemotherapy for metastatic breast cancer.
• The time-to-chemotherapy analysis was post hoc, meaning it was not part of the original statistical plan. While the results are compelling, they should be considered exploratory.
• The study was conducted before and during the early phase of the COVID-19 pandemic. While no COVID-19 cases were reported, the pandemic could have subtly affected patient follow-up, treatment decisions, or survival data in ways that are difficult to quantify.

Recommendations for Patients

Based on the SOLAR-1 results and the broader body of evidence, here are practical recommendations for patients with advanced breast cancer:

1. Request PIK3CA testing. If you have HR+/HER2− advanced breast cancer, ask your oncologist whether your tumor has been tested for PIK3CA mutations. This can be done on tumor tissue (a biopsy or surgical specimen) and increasingly on blood samples (liquid biopsy using circulating tumor DNA). The finding of a PIK3CA mutation opens the door to alpelisib-based therapy.
2. Discuss alpelisib with your oncologist if you are PIK3CA-mutated. The combination of alpelisib and fulvestrant has demonstrated significant progression-free survival benefits, a numeric overall survival improvement, and a meaningful delay in the need for chemotherapy. This may be an appropriate option if your disease has progressed on or after aromatase inhibitor therapy.
3. Understand that survival benefit may vary. If your cancer has spread to the lungs or liver, the survival benefit appears particularly substantial (14.4 months in this analysis). Even if you do not have visceral metastases, the progression-free survival benefit and delay in chemotherapy apply broadly.
4. Plan for monitoring. If you start alpelisib, work with your care team to monitor for known side effects, especially rash and elevated blood sugar. Regular blood glucose checks and skin care routines can help manage these issues early, before they become serious.
5. Do not be discouraged by the statistical nuance. The overall survival result did not meet the very strict statistical bar set by the study design, but the pattern of benefit across multiple endpoints (PFS, PFS2, time to chemotherapy, and the direction of the OS effect) is consistent. Clinical benefit is about more than a single P-value.
6. Ask about clinical trials. If alpelisib is not an option for your specific situation, ask your oncologist about other clinical trials for PIK3CA-mutated breast cancer, including studies of next-generation PI3K inhibitors and combinations with other targeted agents.
7. Consider a second opinion at a cancer center. Breast cancer treatment is rapidly evolving, and comprehensive cancer centers with expertise in genomic testing may offer additional perspective on the best sequencing of treatments for your specific tumor profile.

Frequently Asked Questions

What is PIK3CA-mutated advanced breast cancer?

It is a subtype of hormone receptor-positive, HER2-negative advanced breast cancer that has a mutation in the PIK3CA gene. This mutation occurs in 28% to 46% of patients and is linked to resistance to chemotherapy and a worse overall prognosis, making targeted treatment important.

Which patients appeared to benefit most from alpelisib?

Those with lung or liver metastases had a median overall survival of 37.2 months versus 22.8 months on placebo, a 14.4-month gain. Patients whose PIK3CA mutation was detected in blood also showed a 9.2-month survival improvement, though these subgroup findings come from small numbers.

What are the common side effects of alpelisib plus fulvestrant?

The most notable side effect was rash, occurring in 54% of patients on alpelisib versus 9% on placebo, but most cases were low grade and manageable. Elevated blood sugar (hyperglycemia) was also seen. Only 3% of patients stopped alpelisib due to side effects.

Should I ask my doctor about PIK3CA testing?

If you have hormone receptor-positive, HER2-negative advanced breast cancer, asking about PIK3CA testing is reasonable. It can be done on tumor tissue or blood (liquid biopsy). Finding this mutation is necessary to determine if alpelisib-based therapy might be an option for you.

Does the survival result mean alpelisib is not effective?

No. Although the overall survival improvement was not statistically significant, the trial showed a significant progression-free survival benefit and a significant delay in chemotherapy. The pattern across multiple endpoints supports the value of alpelisib for PIK3CA-mutated disease; discuss with your oncologist.

If I have PIK3CA-mutated HR+/HER2- advanced breast cancer and my oncologist recommends alpelisib plus fulvestrant, when should I get a second opinion?

A second opinion is reasonable before starting alpelisib plus fulvestrant, particularly to confirm PIK3CA testing was done on tumor tissue or blood, since the benefit of alpelisib was specific to patients with PIK3CA mutations. It is also worth seeking review if you have lung or liver metastases, where median overall survival was 37.2 months versus 22.8 months on placebo, or if you are weighing how long chemotherapy can be delayed. Diagnostic Detectives Network provides independent expert second opinions.

Source Information

Original Article: "Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced breast cancer: final overall survival results from SOLAR-1"

Authors: F. André, E. M. Ciruelos, D. Juric, S. Loibl, M. Campone, I. A. Mayer, G. Rubovszky, T. Yamashita, B. Kaufman, Y.-S. Lu, K. Inoue, Z. Pápai, M. Takahashi, F. Ghaznawi, D. Mills, M. Kaper, M. Miller, P. F. Conte, H. Iwata, and H. S. Rugo

Publication: Annals of Oncology, Volume 32, Issue 2, February 2021, pages 208–217. Published online November 25, 2020. DOI: https://doi.org/10.1016/j.annonc.2020.11.011

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02437318

This patient-friendly article is based on peer-reviewed research. It is intended for educational purposes and does not constitute medical advice. Patients should discuss their individual treatment options with their healthcare providers.