PH3, RANDOMIZED, OPEN-LABEL, EVALUATING EFFICACY AND SAFETY OF ADJ. GIREDESTRANT COMPARED W/ DR. CHOICE OF ADJ. ENDOCRINE MONOTHERAPY IN PTS. W/ EST. RECEPTORPOS., HER2 NEG. EARLY BC
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTORPOSITIVE, HER2-NEGATIVE EARLY BREAST CANCER
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie
Trial Phone: 321.843.2026 ; 321-841-1077
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IRB No: PRO00053936
Protocol Abbrev: NSABP B-61
Principal Investigator: Ana Elisa Cuesta Fernandez, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: lidERA/ GO42784
Treatment: Eligible participants will be randomly assigned in a 1:1 ratio to one of the following treatment arms: Arm A (experimental arm): giredestrant 30 mg once a day Arm B (control arm): TPC dosing according to local prescribing information Endocrine Therapy of Physician’s Choice is limited to either tamoxifen or one of the specified third-generation AIs: anastrozole, letrozole, or exemestane.
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04961996
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Objective
The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with this type of cancer.
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Key Eligibility
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 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). 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.
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 a 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.
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 Performance (ECOG) Performance Status 0, 1, or 2
Able and willing to swallow and retain 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 or inflammatory breast cancer
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.
A history of any other malignancy within 5 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
Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including 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
Known issues with swallowing oral medication
A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
A malabsorption syndrome or other condition that would interfere with enteral absorption
Uncontrolled inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery
A major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during study treatment
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
