| Title |
A phase 3, randomized, open-label, multicenter trial of ARV-471 (PF-07850327) vs fulvestrant in participants with estrogen receptor-positive, her2-negative advanced breast cancer whose disease progressed after prior endocrine based treatment for advanced disease |
| Protocole ID |
VERITAC-2 |
| ClinicalTrials.gov ID |
NCT05654623 |
| Cancer Type(s) |
Breast |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
ARV-471 (PF-07850327) versus fulvestrant |
| Institution |
CISSS DES LAURENTIDES
 HOPITAL DE SAINT-JEROME
290 Rue de Montigny, Saint-Jérôme, QC, J7Z 5T3
|
| City |
|
| Principal Investigator |
Dr. Ghislain Cournoyer
|
| Coordinator |
Yanick Sardin Laframboise
450-431-1020 poste 23429
|
| Status |
Closed |
| Activation Date |
|
| Eligibility Criteria |
- Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
- Confirmed diagnosis of ER+/HER2- breast cancer
- Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
- One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one line of CDK4/6 inhibitor is allowed in any setting.
- ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
- Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy.
- Radiological progression during or after the last line of therapy.
- Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Participants should be willing to provide blood and tumor tissue
|
| Exclusion Criteria |
- Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
- Prior treatment with:
- ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
- other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting
- prior chemotherapy for advanced/metastatic disease
- Inadequate liver, kidney and bone marrow function
- Active brain metastases
- Participants with significant concomitant illness
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| |
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Groupe d'étude en oncologie du Québec