RecruitingPhase 2

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

CO

FL

IA

LA

MD

ME

MI

NC

NE

NJ

NM

NY

TN

TX

VA

WA

WI