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Phase 3, Randomized, Open-Label Study of ARV-471 (PF-07850327) Plus Palbociclib vs Letrozole Plus Palbociclib in Participants With ER(+)/HER2(-) Advanced Breast Cancer (VERITAC-3)
EU CTIS ID: 2022-500545-24-00
What this study is testing
Study Lead-in: To determine the RP3D of palbociclib when given in combination with ARV-471 Phase 3: To demonstrate that vepdegestrant in combination with palbociclib is superior to letrozole plus palbociclib in prolonging progression free survival (PFS) in participants with ER(+)/HER2(-) aBC who have not received any prior systematic anticancer therapy for their advanced disease.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.• Pre-peri menopausal female and male participants must agree on LHRH use. • WOCBP participants and male participants must agree on contraception.
- Phase 3 ONLY. Participants must provide a blood sample AND a tumor sample collected at the time of diagnosis of locally advanced/metastatic disease. If not available, a de novo biopsy is required. The sole exception is those patients with bone only disease for whom archival tumor sample at initial diagnosis is acceptable.
- Histological or cytological confirmation of BC with evidence of locoregionally advanced or metastatic disease, not amenable to surgical resection or radiation therapy with curative intent. •Documented ER(+), defined as ER(+) ≥1% stained cells on the most recent tumor biopsy, ie, at diagnosis of recurrence or metastatic disease (Allison et al, 2020). The sole exception is those patients with bone only disease for whom ER(+) using archival tissue at initial diagnosis is acceptable. •Documented HER2(-) tumor by either IHC or in-situ hybridization per ASCO/CAP guideline (Wolff et al, 2018). •Participants who have bilateral BCs which are both ER(+)/HER2(-) are eligible.
- No prior systemic anti-cancer therapy for their locoregionally advanced or metastatic disease.
- At least 1 measurable lesion as defined by RECIST v1.1. Bone only disease: participants with only non-measurable lesions are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
You likely can't join if
- Prior treatments: CDK4/6i, vepdegestrant, fulvestrant, elacestrant and other investigational agents (including novel ET, any SERDs, SERCAs, CERANs) in any setting.
- Lack of adequate bone marrow, liver and kidney function.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Refractory nausea and vomiting, chronic GI disease, GI ulcer, GI bleeding, inability to swallow the formulated product or previous significant gastric (total or partial), bowel resection that would preclude adequate absorption of study interventions.
See the full eligibility criteria
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.• Pre-peri menopausal female and male participants must agree on LHRH use. • WOCBP participants and male participants must agree on contraception.
- Phase 3 ONLY. Participants must provide a blood sample AND a tumor sample collected at the time of diagnosis of locally advanced/metastatic disease. If not available, a de novo biopsy is required. The sole exception is those patients with bone only disease for whom archival tumor sample at initial diagnosis is acceptable.
- Histological or cytological confirmation of BC with evidence of locoregionally advanced or metastatic disease, not amenable to surgical resection or radiation therapy with curative intent. •Documented ER(+), defined as ER(+) ≥1% stained cells on the most recent tumor biopsy, ie, at diagnosis of recurrence or metastatic disease (Allison et al, 2020). The sole exception is those patients with bone only disease for whom ER(+) using archival tissue at initial diagnosis is acceptable. •Documented HER2(-) tumor by either IHC or in-situ hybridization per ASCO/CAP guideline (Wolff et al, 2018). •Participants who have bilateral BCs which are both ER(+)/HER2(-) are eligible.
- No prior systemic anti-cancer therapy for their locoregionally advanced or metastatic disease.
- At least 1 measurable lesion as defined by RECIST v1.1. Bone only disease: participants with only non-measurable lesions are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
- Participants must be adults with ER+/HER2- A/MBC, who have not been previously treated with prior therapies for advanced/metastatic disease. Participants must have at least 1 measurable lesion as per RECIST v1.1, or for those with bone only disease, those with only non-measurable lesions are eligible.
- Prior treatments: CDK4/6i, vepdegestrant, fulvestrant, elacestrant and other investigational agents (including novel ET, any SERDs, SERCAs, CERANs) in any setting.
- Lack of adequate bone marrow, liver and kidney function.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Refractory nausea and vomiting, chronic GI disease, GI ulcer, GI bleeding, inability to swallow the formulated product or previous significant gastric (total or partial), bowel resection that would preclude adequate absorption of study interventions.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Japan
- China
- Switzerland
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Japan; China; Switzerland; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.