Combination Chemotherapy for Breast Cancer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effect and best dose of neratinib and to see how well it works with paclitaxel and with or without pertuzumab and trastuzumab before combination chemotherapy in treating patients with breast cancer that has spread to other places in the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pertuzumab and trastuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving neratinib, pertuzumab, trastuzumab, paclitaxel and combination chemotherapy may work better in treating patients with breast cancer.

Research Team

Rachel M Layman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with confirmed breast cancer that has spread and who can take oral meds. They must have good heart function, normal blood counts, liver function within certain limits, and agree to use birth control. It's not for those breastfeeding, with a history of certain autoimmune diseases or other recent cancers, uncontrolled high blood pressure, serious infections or hepatitis B/C.

Inclusion Criteria

Able to provide written informed consent for the trial

Your platelet count is at least 100,000 per microliter.

Your hemoglobin level is at least 9 grams per deciliter.

Exclusion Criteria

I had surgery to remove part or all of my breast tumor.

I haven't had any cancer except for some skin cancers and treated cervical cancer in the last 5 years.

I have not received any cancer treatments for my current diagnosis, except if I'm in phase Ib of cohort 1.

Treatment Details

Interventions

• Cyclophosphamide (Chemotherapy)
• Doxorubicin (Chemotherapy)
• Neratinib (Tyrosine Kinase Inhibitor)
• Paclitaxel (Chemotherapy)
• Pertuzumab (Monoclonal Antibodies)
• Trastuzumab (Monoclonal Antibodies)

Trial Overview The study tests neratinib combined with paclitaxel chemotherapy and possibly pertuzumab and trastuzumab before more chemo. The goal is to find the best dose of neratinib and see how well it works in stopping tumor growth when used with these drugs in metastatic or locally advanced breast cancer.

Participant Groups

Group I: Group C (Cohort 2) Experimental Treatment 5 Interventions

Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery/ Patients then receive doxorubicin and cyclophosphamide as in Group B. Patients then undergo standard of care surgery.

Group II: Group B (Cohort 1 Phase II) Experimental Treatment 7 Interventions

Patients receive neratinib, paclitaxel, pertuzumab, and trastuzumab as in Group A. Patients then receive doxorubicin IV and cyclophosphamide IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.

Group III: Group A (Cohort 1 Phase Ib) Experimental Treatment 5 Interventions

Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15, pertuzumab IV over 1 hour on day 1, and trastuzumab IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression or excessive toxicity with metastatic disease may receive up to 4 additional courses and with locally advanced disease may receive up to 2 additional courses.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+