In this article
FDA Approval for Advanced HR-Positive Breast Cancer
Capivasertib (Truqap, AstraZeneca Pharmaceuticals) in combination with fulvestrant was approved by the Food and Drug Administration on November 16, 2023, for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This approval is specifically for patients with one or more PIK3CA/AKT1/PTEN alterations, as identified by an FDA-approved test, who have experienced disease progression after at least one endocrine-based treatment in the metastatic setting or recurrence within 12 months of completing adjuvant therapy.
The FDA authorized the FoundationOne®CDx test as a companion diagnostic device for identifying breast cancer patients eligible for therapy with capivasertib and fulvestrant.
CAPItello-291 Clinical Trial Study Design
LLO-291 (NCT04305496) was a randomized, double-blind, placebo-controlled, multicenter trial involving 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer. Among them, 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations. All patients needed to show progression while on aromatase inhibitor-based treatment. Patients may have undergone a maximum of two previous rounds of endocrine therapy and one round of chemotherapy for locally advanced or metastatic illness.
Patients were randomly assigned in a 1:1 ratio to receive either capivasertib 400 mg or a placebo orally twice daily for 4 days, with 3 days off therapy each week, across a 28-day treatment cycle. Both patients in the investigational and control groups were administered Fulvestrant 500 mg intramuscularly on cycle 1 days 1 and 15 and subsequently every 28 days. Patients were treated until disease progression or unacceptable toxicity occurred.
Efficacy Results and Progression-Free Survival (PFS)
The main goal of the study was to measure how long patients lived without their disease getting worse, which was checked by doctors in all patients and specifically in those with PIK3CA/AKT1/PTEN Both the total population and patients with tumors containing PIK3CA/AKT1/PTEN alterations showed statistically significant differences in progression-free survival (PFS).
Among the 289 patients with tumors that had PIK3CA/AKT1/PTEN changes, those taking capivasertib and fulvestrant lived without their disease worsening for an average of 7.3 months, while those taking a placebo with fulvestrant had an average of 3 The Hazard Ratio (HR) was 0.50 (95% CI: 0.38, 0.65) with a p-value of less than 0.0001.
An exploratory analysis of progression-free survival (PFS) in 313 patients (44%) devoid of PIK3CA/AKT1/PTEN alterations indicated a hazard ratio (HR) of 0.79 (95% CI: 0.61, 1.02). This suggests that the outcomes in patients with PIK3CA/AKT1/PTEN alterations primarily drove the observed difference in the overall population.
Common Side Effects and Dosage Recommendations
The most frequent adverse reactions (reported in ≥20% of patients), including laboratory abnormalities, were diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting, and stomatitis.
The suggested capivasertib dosage is 400 mg taken orally twice a day, about 12 hours apart, with or without food, for 4 consecutive days, followed by 3 days off, until disease progression or unacceptable toxicity.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.