Studieoverzicht - 2022-03 ALPHABET

 
Number 2022-03 ALPHABET
Nickname ALPHABET
Status Open Date: 21-08-2023
Inclusion closed
Other study number(s) GEICAM/2017-01_IBCSG 62-20_BIG 18-04
Participating parties/groups GEICAM - BIG - IBCSG
Full title A Randomized Phase III Trial Of Trastuzumab + Alpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy In Patients With PIK3CA Mutated Previously Treated Her2+ Advanced Breast Cancer
Phase and type Randomized Phase III
Age ≥18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2+, any HR
Target sample size 252 (global, 24 NL)
Actual accrual 18 (global, 0 NL) Date: 11-07-2023
Estimated study completion date 31-07-2026
CCMO approval Yes Date: 23-05-2022 Nr: NL81153.068.22
EudraCT nr. 2020-005639-65
Trial Register NCT05063786
METC approval Yes Date: 03-02-2023 METC: Academisch Ziekenhuis Maastricht Nr: METC22-025
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website
Sponsor GEICAM - delegated sponsor NL: BOOG
Principal Investigator(s)
Study manager S.M. (Susan) van den Berg, BOOG Study Center
Central datamanagement and randomization GEICAM
Monitoring IKNL
Local datamanagement ziekenhuis zelf
Funding Novartis via BIG/GEICAM
Extra

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):

 

Centra open voor inclusie:

  • VieCuri Medisch Centrum, Venlo
  • Radboudumc, Nijmegen
  • Admiraal de Ruyter Ziekenhuis, Goes
  • Meander Medisch Centrum, Amersfoort

 

5 andere centra zijn momenteel in opstart voor deze studie.

 

Documents (protected):
In order to see this content you need to be logged on.

Login.

Back