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Capivasertib + Fulvestrant for Advanced Breast Cancer (CAPItello-291 Trial)
CAPItello-291 Trial Summary
This trial is testing a new cancer drug to see if it is more effective than current treatments for women with breast cancer that has spread.
CAPItello-291 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCAPItello-291 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803CAPItello-291 Trial Design
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Who is running the clinical trial?
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- My breast cancer is hormone receptor positive and HER2 negative.My breast cancer progressed while on or after AI treatment.A tumor sample from the primary or recurrent cancer is needed for central testing.I've had more than one chemotherapy treatment for my advanced cancer, not counting treatments before surgery.I haven't taken certain cancer or immune system treatments in the last 3 weeks.You have uncontrolled diabetes or bleeding problems, are taking certain blood thinners, are pregnant, or breastfeeding.I am an adult willing to undergo hormone therapy if pre-menopausal.My cancer has spread or worsened and cannot be surgically removed with the aim of curing it.I have cancer that can be measured by scans or I have a certain type of bone lesion.My heart health is not within the normal range, including issues with heart rhythm or blood pressure.I am fully active and can carry on all my pre-disease activities without restriction.My condition is too severe for hormone therapy, according to my doctor.I have had more than 2 hormone treatments for my advanced cancer.
- Group 1: Capivasertib + fulvestrant
- Group 2: Placebo + fulvestrant
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment involve any minors?
"According to the inclusion criteria for this study, patients aged 18-130 are eligible to apply. There are 67 clinical trials specifically for minors and 2440 research studies available for adults over 65 years old."
What are the main goals that researchers hope to achieve with this clinical trial?
"The goal of this study is to improve Progression-Free Survival (PFS) in patients with cancer. Additionally, the study will measure Duration of Response (DoR), Response Rate (ORR), and Time to definitive deterioration of the ECOG performance status."
Are new participants being recruited for this trial at this time?
"The clinicaltrials.gov website confirms that this study is still looking for eligible patients. The listing was first created on April 16th, 2020 and edited most recently on October 3rd, 2022."
Has Capivasertib received FDA regulatory approval?
"Capivasertib's safety is estimated to be a 3. This score was given because capivasertib is in Phase 3 of clinical trials, which suggests that there is some evidence supporting the efficacy of the drug as well as multiple rounds of data collected on its safety profile."
What other experiments have there been with Capivasertib?
"Out of the 157 clinical trials currently underway for Capivasertib, 35 are in Phase 3. Some of these tests are happening in Shanghai, but there are 9683 total locations worldwide where researchers are running clinical trials for Capivasertib."
What is the primary disease or condition that Capivasertib is designed to improve?
"Capivasertib is often used to treat patients that have undergone endocrine therapy. Additionally, this medication can be given to those suffering from disease, breast cancer, and pik3ca gene mutation."
To whom is this research project available?
"This trial is looking for 834 patients with locally advanced (inoperable) or metastatic breast cancer. The ages of the participants must fall between 18 and 130, and they must meet the following criteria: Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study"
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