A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests zanidatamab with chemotherapy before breast cancer surgery. It will look at how safe the treatment is and how well it works in people with newly diagnosed stage II or III HER2-positive breast cancer, which has extra HER2 protein.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have newly diagnosed stage II or III invasive breast cancer, confirmed by a tissue test. Invasive means it has grown into nearby breast tissue.
- Have HER2-positive breast cancer and know whether hormones help the tumor grow.
- If there is more than one tumor, the largest must be at least 2 cm across and HER2-positive. Your doctor must decide to treat the cancer as HER2-positive.
- Agree to surgery after study treatment to remove the breast or just the cancer.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have organs that work well enough. A heart scan within 6 weeks before study group assignment must show that your heart pumps out at least 50% of the blood with each beat.
- Take adequate steps to prevent pregnancy.
- If you have HIV, have a CD4 immune cell count above 350, no detectable virus in your blood, and take neither protease inhibitors nor cobicistat.
Who can't join
- Have stage IV breast cancer, which has spread to distant body parts, or cancer in both breasts.
- Have a severe or uncontrolled health problem that could affect study participation, uncontrolled high blood pressure, or major symptoms from nerve damage.
- Have an active uncontrolled infection or active hepatitis B or C, which are liver infections.
- Have had a life-threatening allergic reaction to antibody medicines, lab-made proteins, or study drug ingredients; or have a known allergy to any study treatment, including chemotherapy.
- Have had another cancer diagnosed in the past 5 years, except treated non-melanoma skin cancer or cancers that stayed where they started, including melanoma in situ. Any past invasive breast cancer or DCIS (cancer inside milk ducts) in the same breast rules you out.
- Have already had treatment for invasive breast cancer, including surgery, chemotherapy, HER2-targeted drugs, radiation, hormone treatment, or experimental treatment.
- Plan to use another experimental drug or cancer treatment not included in this study at the same time.
- Received a live vaccine within 4 weeks before joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Has newly diagnosed 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 6 weeks prior to randomization. 9. Adequate contraceptive precautions 10. Participants with known HIV are eligible unless: 1. CD4+ T Cell count is less than or equal to 350 microliters (uL) 2. Detectable viral load, or 3. Receiving protease inhibitors or cobicistat 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. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible. 10. Was treated with surgery, 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
Study sites (29)
CA
- Oncology Institute · Long Beach, CA 90805More trials in Long Beach
- Cancer & Blood Research Center · Los Alamitos, CA 90720More trials in Los Alamitos
CO
- Rocky Mountain Cancer Centers · Denver, CO 80218More trials in Denver
FL
- Holy Cross Hospital · Fort Lauderdale, FL 33308More trials in Fort Lauderdale
- The Oncology Institute · Lakeland, FL 33812More trials in Lakeland
IA
- Accellacare of McFarland · Ames, IA 50010More trials in Ames
LA
- LSU Health Sciences Center · Shreveport, LA 71103More trials in Shreveport
MD
- Maryland Oncology Hematology · Laurel, MD 20707More trials in Laurel
ME
- New England Cancer Specialists · Scarborough, ME 04074More trials in Scarborough
MI
- Henry Ford Hospital · Detroit, MI 48202More trials in Detroit
NC
- Levine Cancer · Charlotte, NC 28204More trials in Charlotte
NE
- Cancer Partners of Nebraska · Lincoln, NE 68516More trials in Lincoln
- Nebraska Cancer Specialists · Omaha, NE 68124More trials in Omaha
NJ
- Astera Cancer Care (Formerly Regional Cancer Care Associates) · East Brunswick, NJ 08816More trials in East Brunswick
- Medical Oncology Hematology Associates · Newark, NJ 19713More trials in Newark
NM
- The University of New Mexico · Albuquerque, NM 87131More trials in Albuquerque
NY
- Hematology Oncology Associates of Central New York · Camillus, NY 13031More trials in Camillus
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
TN
- Sarah Cannon Research Institute (Nashville) · Nashville, TN 37203More trials in Nashville
TX
- Texas Oncology DFW · Dallas, TX 75246More trials in Dallas
- The University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- Texas Oncology Gulf Coast · Houston, TX 77024More trials in Houston
- UT Health San Antonio, Mays Cancer Center · San Antonio, TX 78229More trials in San Antonio
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax
- Virginia Oncology Associates · Norfolk, VA 23502More trials in Norfolk
- Shenandoah Oncology · Winchester, VA 22601More trials in Winchester
WA
- Northwest Medical Specialties · Puyallup, WA 98373More trials in Puyallup
- Northwest Cancer Specialists · Vancouver, WA 98648More trials in Vancouver
WI
- University of Wisconsin · Madison, WI 53706More trials in Madison