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Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing

NCT07802626 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1084

Last updated 2026-09-03

No results posted yet for this study

Summary

The purpose of this research is to see if adding the investigational targeted drug capivasertib to standard endocrine therapy (hormone-blocking treatment) combined with a medicine that slows cancer cell growth can improve response to treatment for patients with metastatic breast cancer that's hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative.

Conditions

  • HR Positive/HER-2 Negative Breast Cancer

Interventions

DRUG

NSAI + CDK4/6i

NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles

DRUG

NSAI + CDK4/6i + Capivasertib

NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles; Capivasertib: Dosed 4 days on and 3 days off weekly, every cycle

DRUG

Fulvestrant + CDK4/6i + Capivasertib

NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles Capivasertib: Dosed 4 days on and 3 days off weekly, every cycle Fulvestrant: Dosed days 1 and 15 of Cycle 1 and Day 1 of Cycles 2+

DRUG

NSAI + CDK4/6i

NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles

DIAGNOSTIC_TEST

Guardant Reveal

ctDNA Assay

Sponsors & Collaborators

  • SWOG Clinical Trials Partnerships, LLC

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Guardant Health, Inc.

    collaborator INDUSTRY

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Kevin Kalinsky, M.D. · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2034-10-30
Completion
2035-10-30
FDA Device
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802626 on ClinicalTrials.gov