Breast CancerOpen to EnrollmentPhase 3

BREAST: ADJUVANT: ER+, HER2-: Substudy 1: liDERA

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

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Study snapshot

Title: Hoffman-La Roche GO42784 Substudy 1 ER+/HER2- adjuvant breast
Malignancy: Breast cancer, IDC, ER+ breast cancer
Stage: Stage 2
Disease setting: Adjuvant/Post-surgical
Line of therapy: Adjuvant
Investigational agent: Giredestrant
Drug class: SERD
Principal investigator: Greg Vidal, MD, PhD
Sponsor: Hoffman La-Roche
Path: ER+, HER2- adenocarcinoma
Randomized: No
ClinicalTrials.gov ID: NCT04961996

Eligibility and objectives

Key eligibility criteria details

ER positive, HER2 negative breast cancer
- Muticentric and multifocal also eligible if all tumors are ER+/HER2-
Must have undergone definitive surgery of their primary breast tumor and axillary lymph nodes
Must have finished adjuvant chemotherapy prior to randomization (if chemo was indicated)
Resolution of all toxic effects of prior chemo
Both node positive and node negative disease are eligible
ECOG PS 0-2
Not receiving and no plan to receive a CDF4/6 inhibitor as adjuvant therapy
No prior malignancy within 3 years
No prior endocrine treatment

Objective

Primary
- IDFS
Secondary
- OS
- IDFS including non-breast cancers
- DFS
- Distant recurrence free survival
- Locoregional recurrence free interval
- QOL
- AEs

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details