A clinical trial to compare the effectiveness and safety of giredestrant with a subcutaneous combination of pertuzumab and trastuzumab versus subcutaneous pertuzumab and trastuzumab alone in people with locally advanced or metastatic breast cancer, with HER2 and oestrogen receptor positivity.

Phase 1

Recruiting

• Conditions: ocally-Advanced or Metastatic breast cancer (MBC); MedDRA version: 23.0Level: LLTClassification code: 10070575Term: Estrogen receptor positive breast cancer Class: 10029104; MedDRA version: 23.0Level: PTClassification code: 10065430Term: HER2 positive breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500014-26-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 812

Inclusion Criteria

Participants (females, regardless of menopausal status, and males) who are aged >=18 years at the time of signing Informed Consent Form, Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection, At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Disease-free interval from completion of adjuvant or neoadjuvant systemic nonhormonal treatment to recurrence of >=6 months, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, Left ventricular ejection fraction (LVEF) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)

Exclusion Criteria

Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting, Previous treatment with approved or investigative anti- human epidermal growth factor receptor 2 (HER2) agents, Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better, Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy, History of persistent Grade >=2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy, For pre- and perimenopausal women, and men: 1) Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa) 2) Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of endocrine therapy (ET) that requires gonadal function suppression, Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B, Refrain from consumption of grapefruit or grapefruit juice, grapefruit supplements, or Seville oranges (potent CYP3A enzyme inhibitors) for at least 3 days prior to initiation of giredestrant in Arm B and throughout the maintenance phase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified