| Title |
An interventional safety and efficacy phase 1b/2, open-label umbrella study to investigate tolerability, pk, and antitumor activity of ARV-471 (PF-07850327), an oral proteolysis targeting chimera, in combination with other anticancer treatments in participants aged 18 years and over with ER+ advanced or metastatic breast cancer, sub-study B (ARV-471 in combination with ribociclib) |
| Protocole ID |
TACTIVE-U |
| ClinicalTrials.gov ID |
NCT05573555 |
| Cancer Type(s) |
Breast |
| Phase |
Phase I-II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
ARV-471 (PF-07850327) |
| Institution |
CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
 HOPITAL DE CHICOUTIMI
305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
|
| City |
|
| Principal Investigator |
Dr. José Luiz Miranda Guimaraes
|
| Coordinator |
Alexandra Simard
418-541-1000 poste 3163
|
| Status |
Recruiting |
| Activation Date |
01-08-2023 |
| Eligibility Criteria |
- histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amendable to surgical resection with curative intent (≥1% ER+ stained cells on the most recent tumor biopsy).
- prior anticancer therapies: up to 2 lines of prior therapies for advanced/metastatic disease; 1 line of any CDK4/6 inhibitor-based regimen is required (in any setting eg adjuvant, metastatic)
- at least 1 measurable lesion as defined by RECIST v1.1.
- ECOG PS ≤1.
|
| Exclusion Criteria |
- visceral crisis at risk of life-threatening complications in the short term
- known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
- newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 14 days prior to enrollment in the of study.
- history of any other tumor malignancies within the past 3 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.
- inflammatory breast cancer
- impaired cardiovascular function or clinically significant cardiovascular diseases
- concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
- renal impairment, not adequate liver function and/or bone marrow function
- known active infection
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Groupe d'étude en oncologie du Québec