| TITRE |
(EN) An interventional, open-label, randomized, multicenter phase 3 study of PF-07220060 plus fulvestrant compared to investigator's choice of therapy in participants over 18 years of age with hormone receptor-positive, HER2-negative advanced/metastatic breast cancer whose disease progressed after prior CDK 4/6 inhibitor-based therapy |
| PROTOCOLE ID |
C4391022 |
| CLINICAL TRIAL.gov ID |
NCT06105632 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
305, rue Saint-Vallier, CP 5006
|
| VILLE |
Chicoutimi
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
José Luiz Miranda Guimaraes
|
| COORDONATEUR(RICE) |
Sabrina Côté
sabrina.cote.inf@ssss.gouv.qc.ca
418-541-1000 poste 3065
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
- Documented HER2-negative tumor
- Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
- Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
|
| CRITÈRES D'EXCLUSION |
(EN)
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with any of the following:
- Everolimus or investigational anti-cancer agents in any setting
- Prior chemotherapy in the advanced setting
- Radiation within 2 weeks of randomization
- Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
|
