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NCT07102381 | RECRUITING | HER2-positive Breast Cancer

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Sponsor:

Jazz Pharmaceuticals

Brief Summary:

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Condition or disease

HER2-positive Breast Cancer

Breast Cancer

Intervention/treatment

Zanidatamab

Paclitaxel

Docetaxel

Carboplatin

Trastuzumab

Pertuzumab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 125 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Actual Study Start Date : 2025-09-24
Estimated Primary Completion Date : 2028-01-01
Estimated Study Completion Date : 2030-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Has Stage II or III histologically confirmed invasive breast carcinoma.
  • 2. Has histologically confirmed HER2-positive breast cancer
  • 3. Has a known hormone receptor (HR) status of the primary tumor
  • 4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
  • 5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
  • 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 7. Adequate organ function
  • 8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
  • 9. Adequate contraceptive precautions
Exclusion Criteria
  • 1. Has Stage IV (metastatic) breast cancer.
  • 2. Has bilateral breast cancer.
  • 3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
  • 4. Has uncontrolled hypertension
  • 5. Has significant symptoms from peripheral neuropathy
  • 6. Has an active uncontrolled infection
  • 7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
  • 8. Known active hepatitis B or C infection.
  • 9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
  • 10. Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
  • 11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
  • 12. Receipt of a live vaccine within 4 weeks prior to enrollment
  • 13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Location Details

NCT07102381

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Oncology Institute

Long Beach, California, United States, 90805

RECRUITING

United States, Colorado

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

The Oncology Institute

Lakeland, florida, United States, 33812

RECRUITING

United States, Iowa

Accellacare of McFarland

Ames, Iowa, United States, 50010

RECRUITING

United States, Louisiana

LSU Health Sciences Center

Shreveport, Louisiana, United States, 71103

RECRUITING

United States, Maine

New England Cancer Specialists

Scarborough, Maine, United States, 04074

RECRUITING

United States, Maryland

Maryland Oncology Hematology

Laurel, Maryland, United States, 20707

RECRUITING

United States, Nebraska

Cancer Partners of Nebraska

Lincoln, Nebraska, United States, 68516

RECRUITING

United States, Nebraska

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68124

RECRUITING

United States, New Jersey

Astera Cancer Care (Formerly Regional Cancer Care Associates)

East Brunswick, New Jersey, United States, 08816

RECRUITING

United States, New Jersey

Medical Oncology Hematology Associates

Newark, New Jersey, United States, 19713

RECRUITING

United States, New York

Hematology Oncology Associates of Central New York

Camillus, New York, United States, 13031

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute (Nashville)

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology DFW

dallas, Texas, United States, 75246

RECRUITING

United States, Texas

The University of Texas Southwestern Medical Center

dallas, Texas, United States, 75390

RECRUITING

United States, Texas

Texas Oncology Gulf Coast

Houston, Texas, United States, 77024

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Virginia

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

RECRUITING

United States, Virginia

Shenandoah Oncology

Winchester, Virginia, United States, 22601

RECRUITING

United States, Washington

Northwest Cancer Specialists

Vancouver, Washington, United States, 98648