Studieoverzicht - 2022-03 ALPHABET
| Principal Investigator(s) | ||||
| Study manager | Dr. A.E. van Leeuwen-Stok (BOOG) | |||
| Central datamanagement and randomization | GEICAM | |||
| Monitoring | IKNL | |||
| Local datamanagement | ziekenhuis zelf | |||
| Funding | Novartis via BIG/GEICAM | |||
| Extra | Nog geen ziekenhuizen open in Nederland. | |||
Design:
International, multicenter, open-label, controlled phase III randomized clinical trial
Objectives:
To determine whether the PI3K inhibitor alpelisib + trastuzumab improve efficacy, as measured by PFS, compared to trastuzumab + chemotherapy of physician's choice (vinorelbine, capecitabine or eribulin) in previously treated HER2+/HR-PIK3CA mutated advanced breast cancer patients.
To determine whether the PI3K inhibitor alpelisib + trastuzumab + fulvestrant improve efficacy, as measured by PFS, compared to trastuzumab + chemotherapy of physician's choice (vinorelbine, capecitabine or eribulin) in previously treated HER2+/HR+ PIK3CA mutated advanced breast cancer patients.
Endpoints:
- Progression Free Survival (PFS)
- Overall Survival (OS)
- Objective Response (OR)
- Safety and tolerability
Main eligibility criteria:
- Documented HER2+ status based on local laboratory determination, preferably on the most recent available FFPE tumor sample, and according to American Society of ClinicalOncology (ASCO)/College of American Pathologists (CAP) international guidelines valid at the time of the assay.
- Documented HR status based on local laboratory, preferably on the most recent available FFPE tumor sample, and according to ASCO/CAP international guidelines valid at the time of the assay. In case of discordance in HR status by different biopsies, we will consider the most recent one. HR+ will be defined as ≥1% positive cells by immunohistochemistry for Estrogen Receptor (ER) and/or Progesterone Receptor (PgR). HR- will be defined as <1% positive cells by immunohistochemistry for both ER and PgR. Considering that there are limited data on endocrine therapy benefit for cancers with 1% to 10% of cells staining ER positive, for the purpose of this study, patients with ER and PgR expression between 1 and 10% (considered to be HR low by the most recent ASCO/CAP guidelines) will be eligible for inclusion in the HR- cohort.
- Patients with a PIK3CA tumor mutation at central laboratory determination, preferably on the most recent available FFPE tumor sample.
- At least 1 but no more than 4 prior lines of anti-HER2 based therapy for metastatic breast cancer (MBC). Maintenance therapy will not count as an additional line of therapy.
- At least 1 prior line of trastuzumab in the metastatic setting, or in the (neo)adjuvant setting (provided the patient relapsed while on therapy or within 6 months after completing adjuvant trastuzumab)
Documents (public):
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