Phase-III STUDY TO DETERMINE SAFETY AND EFFICACY OF GIREDESTRANT COMPARED WITH PHYSICIANSCHOICE IN PATIENTS WITH ESTROGENRECEPTOR POSITIVE, HER2 NEGATIVE EARLYBREAST CANCER
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2022/01/039625
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 ERï?« tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as ï?³ 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
â?? 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).
â?? Participants with suspected metastasis in supraclavicular or internal mammary
nodes should be treated in accordance with standard local guidelines.
â?? 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.
â?? 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 ï?£ 2
- 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 <br/ ><br>giredestrant over the control <br/ ><br>treatment.Timepoint: Baseline , every 3 cycle(as clinically indicated)
- Secondary Outcome Measures
Name Time Method To evaluate health status utility <br/ ><br>scores of participants treated with giredestrant compared with TPCTimepoint: baseline, Cycle 3, Cycle 6, Cycle 9 there after every 3 cycles