A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
18 Years and older, Male and Female
GO42784 (primary)
NCI-2021-09253
2021-000129-28
Summary
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.
In addition, an open-label exploratory substudy will explore the safety and efficacy of
giredestrant in combination with abemaciclib in a subset of the primary study population.
Eligibility
- 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 their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
- 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 Substudy Inclusion Criteria: To be eligible for substudy participation, in addition to meeting the inclusion criteria
in the primary protocol, participants must also meet the following modified criteria:
- Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade =1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. Primary Study
Treatment Sites in Georgia
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