A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Treatments: Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice); Drug: LHRH Agonist; Drug: Giredestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04576455

WO42312

2020-001984-10 (EudraCT Number)

Details and patient eligibility

About

This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who are postmenopausal or premenopausal/perimenopausal
• For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
• Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
• Documented ER-positive tumor and HER2-negative tumor, assessed locally
• Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
• Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Adequate organ function

Exclusion criteria

• Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
• Treatment with any investigational therapy within 28 days prior to randomization
• Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
• Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
• Active cardiac disease or history of cardiac dysfunction
• Pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

303 participants in 2 patient groups

Giredestrant

Experimental group

Treatment:

Drug: LHRH Agonist

Drug: Giredestrant

Physician Choice of Endocrine Monotherapy

Active Comparator group

Description:

The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.

Treatment:

Drug: LHRH Agonist

Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice)