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New treatment option for Locally Advanced (Inoperable) or Metastatic Breast Cancer
Official title Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
ClinicalTrials.gov ID: NCT04862663
What this study is testing
What is Capivasertib?
Capivasertib is an investigational medicine, being studied as a potential treatment for locally advanced (inoperable) or metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Key for both phases:
- Adult females (pre-/peri-/ and post-menopausal), and adult males.
- Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of...
- Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment...
- Adequate organ and bone marrow functions.
You likely can't join if
- for both phases:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose...
- Radiotherapy within 2 weeks prior to study treatment initiation.
- Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.
- Persistent toxicities (CTCAE Grade \>1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is...
- Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and...
See the full eligibility criteria
- Key for both phases:
- Adult females (pre-/peri-/ and post-menopausal), and adult males.
- Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To...
- Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels...
- Adequate organ and bone marrow functions.
- Consent to provide a mandatory FFPE tumour sample. Key only for phase III:
- Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a...
- Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.
- Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.
- Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed...
- for both phases:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
- Radiotherapy within 2 weeks prior to study treatment initiation.
- Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.
- Persistent toxicities (CTCAE Grade \>1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be...
- Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least...
- Any of the following cardiac criteria at screening: (a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate)...
- uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation
- Any of these clinically significant abnormalities of glucose metabolism at screening:
- . diabetes mellitus type I or type II requiring insulin treatment
- . Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol)
- Previous allogeneic bone marrow transplant or solid organ transplant. Key exclusion criteria for the phase III only:
- Any prior treatment with, AKT, PI3K or mTOR inhibitors.
- Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months).
- More than 1 line of chemotherapy for metastatic disease.
- Any line of endocrine-based therapy for inoperable locally advanced or metastatic disease.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
- Napa, California, United States
- Newport Beach, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Santa Rosa, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Quincy, Illinois, United States
- Fort Wayne, Indiana, United States
- Louisville, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Covington, Louisiana, United States
- Annapolis, Maryland, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
+ 220 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Fountain Valley, California, United States; Glendale, California, United States; Los Angeles, California, United States; Napa, California, United States; Newport Beach, California, United States and 234 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.