This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone receptor-positive (HR+), HER2-negative advanced breast cancer who are eligible for this treatment regimen.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol.
. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
. Participants must be aged ≥18 years at the time of signing the ICF.
. Adult females, pre- and/or post-menopausal, and adult males:
. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent.
. Participants with metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as confirmed by local or central testing of tumor tissue and/or circulating tumor DNA (ctDNA).
. Participants eligible for treatment with capivasertib and fulvestrant for metastatic breast cancer.
. ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks.
Exclusion criteria
. A disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment (e.g., symptomatic visceral disease that is potentially life-threatening in the short-term)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Timeframe: At the eight-week mark from the commencement of the capivasertib treatment in the study
2
Number of patients who experience grade 2 or greater rash as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Timeframe: At the eight-week mark from the commencement of the capivasertib treatment in the study
. Malignancies other than breast cancer within five years prior to study treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma or Stage I endometrioid uterine cancer).
. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment.
. Known abnormalities in coagulation such as bleeding diathesis, or treatment anticoagulants precluding intramuscular injections of fulvestrant or LHRH, if applicable.
. Prior exposure to any chemotherapy or anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as LHRH agonists) without appropriate washout period before randomization/enrollment, for example, randomization within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents.
. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.
. Radiotherapy within 2 weeks prior to the first dose of study intervention
. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.