Phase-III STUDY TO DETERMINE SAFETY AND EFFICACY OF GIREDESTRANT COMPARED WITH PHYSICIANSCHOICE IN PATIENTS WITH ESTROGENRECEPTOR POSITIVE, HER2 NEGATIVE EARLYBREAST CANCER
Phase 3
Active, not recruiting
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2022/01/039625
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
This is a Phase III, global, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with TPC in participants with medium- and high-risk Stage Iï€III histologically confirmed ER+ and HER2 -EBC. Participants will be treated daily with giredestrant or TPC for at least 5 years. During the study, participants will be regularly assessed for efficacy, safety, and health-related quality of life. Participants who complete the 5-year study treatment will enter long-term follow-up for at least 5 years.
Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per treatment group
The total duration of study participation for each individual is expected to be approximately 10 years (5 years of treatment followed by 5 years of follow-up).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 4700
Inclusion Criteria
- Participants who are capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol.
- Participants (females, regardless of menopausal status, and males) who are age 18 years at the time of signing the Informed Consent Form.
- Participants who have documented ER tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as  1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines (Allison et al. 2020).
- Participants who have documented HER2ï€ tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines (Wolff et al. 2018) 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 with bilateral synchronous invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER positivity and HER2 negativity.
- Participants must have undergone definitive surgery of the primary breast tumor(s). With the exception of the situations described below, the margins of the resected specimen must be histologically free of invasive tumor and/or a component of ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the participant must undergo mastectomy to be eligible. Of note, participants with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection. For participants who undergo mastectomy or wide local excision where deep margin abuts the pectoralis fascia, participants with microscopic positive margins are eligible as long as radiotherapy of the chest wall is administered prior to study entry. Participants with positive anterior margins may be eligible if there is no gross disease left behind (radiotherapy as per local guidelines). – Participants with suspected metastasis in supraclavicular or internal mammary nodes should be treated in accordance with standard local guidelines. – If given, radiation therapy (e.g., post-mastectomy or post-lumpectomy) should be administered according to standard guidelines.
- 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. – Participants who are not candidates for adjuvant chemotherapy or decline chemotherapy are permitted.
- Participants for whom 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.
- Participant who have Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0, 1, or 2 etc...
Exclusion Criteria
- Participants who are 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 TPC.
- Participants who have been diagnosed with Stage IV breast cancer.
- Participants who have a history of any prior (ipsilateral and/or contralateral) invasive breast cancer or DCIS. Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
- Participants who have a history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment and a negative urine pregnancy test within 24 hours prior to study treatment initiation.
- Participants who have 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.
- Participants receiving or planning to receive a CDK4/6i as adjuvant therapy.
- Participants who have active cardiac disease or history of cardiac dysfunction,.
- Participants who have had any prior endocrine treatment with selective ERdownregulators, degraders, or AI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate superiority of Baseline , every 3 cycle(as clinically indicated) giredestrant over the control Baseline , every 3 cycle(as clinically indicated) treatment. Baseline , every 3 cycle(as clinically indicated)
- Secondary Outcome Measures
Name Time Method To evaluate health status utility scores of participants treated with giredestrant compared with TPC
Trial Locations
- Locations (34)
All India Institute of Medical Sciences
🇮🇳Bargarh, ORISSA, India
Apex Wellness Hospital
🇮🇳Nashik, MAHARASHTRA, India
ASIAN CANCER HOSPITAL
🇮🇳Jaipur, RAJASTHAN, India
Asirvatham Speciality Hospital
🇮🇳Madurai, TAMIL NADU, India
Chopda Medicare and Research Centre Pvt Ltd
🇮🇳Nashik, MAHARASHTRA, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Erode Cancer Centre
🇮🇳Erode, TAMIL NADU, India
Fortis Hospital Ltd
🇮🇳Bangalore, KARNATAKA, India
Government Medical College and Hosptial Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
HCG Cancer Centre
🇮🇳Ahmadabad, GUJARAT, India
Scroll for more (24 remaining)All India Institute of Medical Sciences🇮🇳Bargarh, ORISSA, IndiaDr Saroj Das MajumdarPrincipal investigator9438884066sarojmajumdar@gmail.com