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Vepdegestrant + Samuraciclib for Advanced Breast Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG PS ≤1

Histological or cytological diagnosis of breast cancer not amenable to surgical resection with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to approximately 3 year

Awards & highlights

Study Summary

This trial studies the safety & effects of vepdegestrant when given with other medicines for advanced metastatic breast cancer. Participants take vepdegestrant & samuraciclib pills daily & have visits every 4 weeks.

Who is the study for?

This trial is for individuals with advanced or metastatic breast cancer that's hormone-sensitive and not responding to prior treatments. Participants can have had up to two previous therapies for advanced disease, including one CDK4/6 inhibitor regimen, and must have at least one measurable lesion. They should be in a relatively stable condition (ECOG PS ≤1) without life-threatening visceral crises, significant lung function issues, recent other cancers except certain skin/cervix ones, inflammatory breast cancer, serious heart diseases or conditions affecting the kidneys, liver or bone marrow.Check my eligibility

What is being tested?

The study tests vepdegestrant combined with samuraciclib taken orally once daily at home by patients with tough-to-treat breast cancer. The goal is to determine the safety and effectiveness of this combination therapy in controlling cancer that has spread beyond the breast.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions from oral cancer medications such as nausea, fatigue, risk of infection due to lowered immunity; specific concerns could also arise from drug interactions leading to heart rhythm problems (QT interval prolongation) or lung issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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My breast cancer cannot be removed with surgery to cure it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to approximately 3 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to approximately 3 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 3 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Drug Drug Interaction: To evaluate the effect of samuraciclib on PK of ARV 471.

Drug Drug Interaction: • To evaluate the effect of ARV 471 on PK of samuraciclib.

Phase 1b: Number of Participants With Dose Limiting Toxicities

+1 more

Secondary outcome measures

Phase 1b and Phase 2: Duration of Response by investigator assessment.

Phase 1b and Phase 2: Plasma concentrations of ARV-471 and samuraciclib.

Phase 1b and Phase 2: Progression Free Survival by investigator assessment.

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ARV-471 in combination with SamuraciclibExperimental Treatment2 Interventions

ARV-471 administered orally QD continuously and Samuraciclib administered orally QD continuously on 28-day cycles

0 / 2Eligibility criteria met

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Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,939 Total Patients Enrolled

111 Trials studying Breast Cancer

36,377 Patients Enrolled for Breast Cancer

Arvinas Estrogen Receptor, Inc.Industry Sponsor

17 Previous Clinical Trials

2,302 Total Patients Enrolled

7 Trials studying Breast Cancer

1,588 Patients Enrolled for Breast Cancer

Carrick Therapeutics LimitedIndustry Sponsor

3 Previous Clinical Trials

232 Total Patients Enrolled

2 Trials studying Breast Cancer

108 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new applicants being accepted into this clinical trial at the present time?

"The information posted on clinicaltrials.gov shows that this medical trial is no longer accepting candidates; it was first created on November 10th, 2023 and last updated four days later. Despite the conclusion of this study, there are 2,761 other studies currently recruiting participants."

Answered by AI

What evidence is there that using ARV-471 and Samuraciclib together has benign effects for people?

"Our team has assigned ARV-471 and Samuraciclib a safety rating of 2, as this is currently classified as a Phase 2 trial with supportive data for safety but not yet efficacy."

Answered by AI

What aims are being sought with this research endeavor?

"This clinical study seeks to evaluate the pharmacokinetic (PK) interactions between samuraciclib and ARV 471 over a period of 28 days. Secondary outcomes such as duration of response, percentage of participants with clinical benefit responses, and progression free survival are also being evaluated by investigator assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)

2024. "TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06125522.

All > Metastatic Breast Cancer