Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
This study is recruiting people with advanced (recurrent or metastatic) ER+/HER2- breast cancer who have had prior treatment with endocrine therapy. Eligible participants will be ranomly allocated to either the Experimental Arm or Active Comparator Arm.
In the Experimental Arm, participants will receive the new hormone treatment (called vepdegestrant or ARV-471) which will be administered orally once daily on a 28-day continuous dosing schedule.
In the Active Comparator Arm, participants will receive the hormone treatment called fulvestrant, which will be administered via intramuscular injection on Days 1 and 15 of Cycle 1, and then on Day 1 of each cycle startted from CD21. Each cycle will be 28-days.
Conditions
This trial is treating people with ER+, HER2- advanced breast cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pfizer
Scientific Title
A Phase 3, Randomized, Open-Labe, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants with Estrogen Reeptor-Positive, HER2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information