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ALPHABET

  • Closed

BOOG 2022-03

General Information

BOOG number

BOOG 2022-03

Nickname

ALPHABET

Status

  • Closed
Date: 11/01/2024

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

Other

De studie is voortijdig gesloten. Overwegingen daarbij waren:

  • De uitdagingen op het gebied van patiënten inclusie en site activering.
  • De lage incidentie van de studiepopulatie en het snel evoluerende behandelingslandschap.
  • De ethische overwegingen om patiënten te blijven rekruteren wetende dat het onwaarschijnlijk is dat de beoogde inclusie bereikt zal worden om de wetenschappelijke vragen te beantwoorden.

 

In Nederland zijn geen patiënten geïncludeerd en wereldwijd slechts 27 patiënten van de benodigde 252 patiënten. Hierdoor worden geen resultaten van deze studie verwacht.

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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