CTRI/2022/01/039625尚未招募3 期
A PHASE III, RANDOMIZED, OPEN-LABEL,MULTICENTER STUDY EVALUATING THEEFFICACY AND SAFETY OF ADJUVANTGIREDESTRANT COMPARED WITH PHYSICIANSCHOICE OF ADJUVANT ENDOCRINEMONOTHERAPY IN PATIENTS WITH ESTROGENRECEPTOR.POSITIVE, HER2-NEGATIVE EARLYBREAST CANCER
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •- 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
研究者
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