Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Part of paid clinical trials in Columbia, Maryland.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT05748834
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tucatinib — DRUG
    Participants will receive tucatinib 300mg by mouth twice daily continuously (days 1-28) of each 28 day cycle.
  • Doxil — DRUG
    Participants will receive Doxil 40mg/m2 intravenously on day 1 of each 28 day cycle (with a maximum cumulative dose of 550mg/m2).

Study Details

This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to: * Learn how well the combination of tucatinib and Doxil works * Learn more about the side effects of the combination of tucatinib and Doxil

Key Dates

Start date
Jul 24, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tucatinib Experimental Treatment Arm
    Participants will receive tucatinib 300mg by mouth twice daily continuously in combination with Doxil 40mg/m2 given intravenously on day 1 of each cycle. Cycles will be 28 days. Up to 36 participants will be enrolled in this Phase 2 study.

Primary Outcome Measure

Objective response rate (ORR) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1. [ Time Frame: Up to approximately 40 months. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Maryland Oncology HematologyColumbiaMaryland21044
Carol Tweed, MD (PRINCIPAL_INVESTIGATOR)
Alliance Cancer SpecialistsBensalemPennsylvania19020
Sramila Aithal, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Erika Hamilton, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203-
Texas Oncology- DFWDallasTexas75246
Joyce O'Shaughnessy, MD (PRINCIPAL_INVESTIGATOR)
Texas Oncology- San AntonioSan AntonioTexas78240
Emmalind Aponte, MD (PRINCIPAL_INVESTIGATOR)
Virginia Oncology AssociatesNorfolkVirginia23502
Nino Balanchivadze, MD (PRINCIPAL_INVESTIGATOR)
Blue Ridge Cancer Care (Oncology & Hematology Assoc of SW Virginia, Inc)SalemVirginia24153
Amanda Gillespie-Twardy, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbia, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Maryland Oncology Hematology· Columbia, MDAlliance Cancer Specialists· Bensalem, PASCRI Oncology Partners· Nashville, TNTennessee Oncology· Nashville, TNTexas Oncology- DFW· Dallas, TXTexas Oncology- San Antonio· San Antonio, TX

Related Studies