Pre-Surgery Chemotherapy + Trastuzumab for Breast Cancer

Palo Alto (17 mi)

Overseen byJesus Anampa, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Albert Einstein College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells o grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients with breast cancer to study in the laboratory may help doctors learn more about how well patients will respond to treatment.

Eligibility Criteria

This trial is for patients with stage IIA-IIIC breast cancer who haven't had prior chemotherapy, radiation, or definitive surgery for the malignancy. They must have documented hormone receptor status and be medically fit for preoperative chemo and surgery. Prior tamoxifen use is allowed if stopped one week before enrollment.

Inclusion Criteria

I have had a biopsy or aspiration of my lymph nodes before starting treatment.

I haven't had chemo, radiation, or major surgery for my cancer, but a sentinel lymph node biopsy is okay.

My breast cancer is confirmed and I plan to have surgery after initial treatment.

The hormone status of my cancer was tested before starting treatment.

Treatment Details

The study tests pre-surgery chemotherapy using doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they kill tumor cells in breast cancer patients. It also involves collecting tissue samples to understand treatment response.

3Treatment groups

Experimental Treatment

Group I: Stratum C (AC followed by paclitaxel)Experimental Treatment5 Interventions

Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.

Group II: Stratum B (paclitaxel followed by AC)Experimental Treatment5 Interventions

Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A.

Group III: Stratum A (HER2-positive disease)Experimental Treatment6 Interventions

Patients receive paclitaxel IV over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks after the last dose of paclitaxel, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: