Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line … (NCT03439046) | Clinical Trial Compass
CompletedPhase 3
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
Italy287 participantsStarted 2018-02-02
Plain-language summary
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and, in patients with a PIK3CA mutation, on second-line treatment with alpelisib plus fulvestrant
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
CORE PHASE Inclusion Criteria:
* Patient has an advanced (locoregionally recurrent or metastatic) breast cancer in first line treatment (treatment naïve for the advanced setting).
* Patient is in post-menopause, defined by one of the following:
* Prior bilateral oophorectomy
* Age ≥60
* Age \<60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range
* Patient has a histologically and/or cytologically confirmed diagnosis of estrogenreceptor positive and/or progesterone receptor positive breast cancer by local laboratory.
* Patient has an HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
* Patient is willing to undergo blood and tumor sample collection for the biological assessments/objectives as scheduled in the protocol.
CORE PHASE Exclusion Criteria:
* Patient who received prior treatment with any CDK4/6 inhibitor.
* Patient who received any prior systemic hormonal therapy or chemotherapy for advanced breast cancer.
Note:
Patients who received neo/adjuvant therapy for breast cancer are eligible. If the prior neo/adjuvant therapy included letrozole or anastrozole, the disease-free interval must be greater than 12 months from the completion of treatment until study ent…
What they're measuring
1
Change from baseline ctDNA alterations to progression disease during Core and Extension Phase
Timeframe: Up to approximately 36 months starting from Baseline of the core phase and Up to approximately 9 months starting from Baseline of the extension phase