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ALPHABET

  • Closed

BOOG 2022-03

General Information

BOOG number

BOOG 2022-03

Nickname

ALPHABET

Status

  • Closed
Date: 22/12/2023

Inclusion closed

11/01/2024

Participating parties / group

GEICAM - BIG - IBCSG

Other study number

GEICAM/2017-01_IBCSG 62-20_BIG 18-04

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

Indication

  • Advanced/Metastatic

Subindication

HER2+, any HR

Description

Alpelisib in PIK3CA-mutated HER2+ advanced breast cancer

Target sample size

252 (global, 24 NL)

Actual accrual

27 (global, 0 NL)
Date: 01/02/2024

Estimated study completion date

31/07/2026

Number of active sites

NL: 5

Contact

Sponsor

GEICAM – delegated sponsor NL: BOOG

Principal Investigator(s)

NL: M. (Maaike) de Boer, MUMC

Study manager

S.M. (Susan) van den Berg, BOOG Study Center

Projectmedewerker: S. (Suzanne) Jager, BOOG Study Center

Central datamanagement and randomization

GEICAM

Monitoring

IKNL

Local datamanagement

ziekenhuis zelf

Funding

GEICAM

Design

International, multicenter, open-label, controlled phase III randomized clinical trial

Participating sites

  • VieCuri Medisch Centrum
  • Radboudumc
  • Admiraal de Ruyter Ziekenhuis
  • Meander Medisch Centrum
  • Diakonessenhuis

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

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)

Regulatory Information

CCMO approval

Yes
Date: 23/05/2022
Nr: NL81153.068.22

EC approval

Yes
Date: 03/02/2023
Nr:METC22-025

EC

Academisch Ziekenhuis Maastricht
Amendments:
Yes
Date Last Amendment: 08/05/2023

EudraCT number

2020-005639-65

Trial Register

NCT05063786

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