TACTIVE-U: An Umbrella Study to Investigate the Safety and Antitumor Activity of vepdegestrant (ARV-471) in Combination With Other Medicines in Adults With ER+ Advanced or Metastatic Breast Cancer, Sub-study C (ARV-471 and Samuraciclib)
- Conditions
- Advanced or Metastatic Breast CancerMedDRA version: 21.1Level: LLTClassification code: 10072737Term: Advanced breast cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507125-41-00
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 67
Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening., Histological or cytological diagnosis of breast cancer. At time of enrollment this must not be amendable to surgical resection with curative intent (=1% ER+ stained cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or in-situ hybridization per ASCO/CAP):•Participants who have bilateral breast cancers that are both ER+/HER2- are eligible.•Tumor block collected at the time of diagnosis with local recurrent or metastatic disease or archival tumor tissue is required for inclusion (Phase 1b and Phase 2)., Prior anticancer therapies: Phase 1b and DDI Assessment Cohort(s): Up to 2 lines of prior therapies for advanced/metastatic disease: •=1 prior chemotherapy (no antibody-drug conjugates permitted); •=2 prior endocrine-based therapies;•No prior experimental endocrine therapy (eg, SERD, CERAN, PROTAC, SERCA) or elacestrant permitted;•1, and only 1, line of any prior CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic)., Participants must have at least 1 measurable lesion as defined by RECIST v1.1. Participants with bone lesions only can be included if at least 1 bone lesion has a measurable component as for RECIST v1.1., ECOG PS =1, no deterioration over the previous 2 weeks.
Participants in visceral crisis at risk of life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and/or peritoneal), pulmonary lymphangitis, and liver involvement >50%., Participants with active bleeding, history of hemolytic anemia or marrow aplasia., Participants with newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and clinically stable (including participants with residual CNS symptoms/deficits) and discontinued anti-seizure medications and corticosteroids for at least 28 days prior to first dose of IMP., Refractory nausea and vomiting, chronic GI disease, GI ulcer, GI bleeding, active inflammatory bowel disease, inability to swallow the formulated product, or previous, significant gastric bowel resection that would preclude adequate absorption of study interventions., History of any other malignancies within the past three years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. All other malignancies must have been curatively treated with no evidence of disease for >3 years. Participants with inflammatory breast cancer are excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method