A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician

Ведущий спонсор: Hoffmann-La Roche

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

• Early Breast Cancer

Тип вмешательства: Drug

Название вмешательства: Giredestrant

Описание: Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Этикетка Arm Group: Arm A: Giredestrant

Тип вмешательства: Drug

Название вмешательства: Endocrine Therapy of Physician's Choice

Описание: The endocrine therapy of physician's choice (TPC) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive TPC daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing TPC after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of TPC should be performed in accordance with the local prescribing information for the respective product.

Этикетка Arm Group: Arm B: Endocrine Therapy of Physician's Choice

Тип вмешательства: Drug

Название вмешательства: LHRH Agonist

Описание: A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Критерии:

Inclusion Criteria: - Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen - Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity - Participants must have undergone definitive surgery of the primary breast tumor(s). - Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization. - Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment) - Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery - Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study. - Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol - Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 - Able and willing to swallow, retain, and absorb oral medication - Adequate organ function Exclusion Criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice - Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study - Receiving or planning to receive a CDK4/6i as adjuvant therapy - Active cardiac disease or history of cardiac dysfunction - Diagnosed with Stage IV breast cancer - A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible. - A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer - Any prior endocrine treatment with selective ER downregulators or degraders or aromatase inhibitors - Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis - Known allergy or hypersensitivity to any of the study drugs or any of their excipients - Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists - A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism - A major surgical procedure unrelated to breast cancer within 28 days prior to randomization - A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study - Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

No

Фамилия: Reference Study ID Number: GO42784 https://forpatients.roche.com/

Телефон: 888-662-6728 (U.S. Only)

Australia

Belgium

Canada

Chile

Costa Rica

Finland

Germany

Greece

Guatemala

Ireland

Israel

Japan

Latvia

Mexico

Philippines

Poland

Portugal

Romania

Spain

Ukraine

United States

2022-01-01

Тип: Sponsor

• Breast Neoplasms

Метка: Arm A: Giredestrant

Тип: Experimental

Метка: Arm B: Endocrine Therapy of Physician's Choice

Тип: Active Comparator

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: None (Open Label)