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NCT04802759 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
A Phase 1 study of Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT04802759 is a Phase 1 study of Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 316 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT04802759, a Phase 1 study of Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib). Cohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.
Conditions Studied
Interventions
- DRUG Ipatasertib
- DRUG Abemaciclib
- DRUG Ribociclib
- DRUG Inavolisib
- DRUG Giredestrant
Study Locations (20)
California
- City of Hope - Duarte
- University of California, San Francisco (UCSF) - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Santa Monica
- Stanford Cancer Institute (SCI) - Stanford
Other
- Rambam Medical Center - Haifa
- Hadassah Ein Karem Hospital - Jerusalem
- Rabin MC - Petah Tikva
- The Chaim Sheba Medical Center - Ramat Gan
New Jersey
- Regional Cancer Care Associates LLC (RCCA) - Freehold Location - Freehold
- Regional Cancer Care Associates LLC ? Howell Division - Howell Township
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- University of Pittsburgh Cancer Institute - Pittsburgh
Victoria
- Peninsula Health-Frankston Hospital - Frankston
- Peter Maccallum Cancer Centre - Melbourne
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- Levine Cancer Institute - Charlotte
Tennessee
- West Cancer Center - Germantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2021-06-22 |
| Est. Completion | 2029-05-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04802759
The ClinicalTrials.gov registry entry for NCT04802759 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Ipatasertib is the first listed.
NCT04802759 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04802759 about?
NCT04802759 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer". This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unaccept...
What is the current status of trial NCT04802759?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 316 participants. The study started on 2021-06-22. Estimated completion is 2029-05-30.
What conditions does trial NCT04802759 study?
This clinical trial studies the following conditions: Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer.
What interventions are being tested in trial NCT04802759?
The interventions under investigation include: Ipatasertib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), Inavolisib (DRUG), Giredestrant (DRUG).
Who is sponsoring clinical trial NCT04802759?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04802759 being conducted?
This trial has 20 study locations across California, Massachusetts, New Jersey, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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