Pre-Surgery Chemotherapy + Trastuzumab for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Prior chemotherapy, irradiation, surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

31 Participants Needed

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 to 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.

Research Team

Jesus Anampa, MD

Principal Investigator

Albert Einstein College of Medicine

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 have or will have metallic clips in my tumor before starting treatment to help with surgery.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Patients receive chemotherapy with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, with trastuzumab for HER2-positive patients

20 weeks

Weekly visits for paclitaxel, every 2 weeks for doxorubicin and cyclophosphamide

Surgery

Patients undergo surgery 2-6 weeks after the last chemotherapy dose

2-6 weeks post-chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Cyclophosphamide
• Doxorubicin Hydrochloride
• Paclitaxel
• Trastuzumab

Trial Overview 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.

Participant Groups

Group I: Stratum III: ER2-positive, HER2-negative Experimental Treatment 3 Interventions

Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET.

Group II: Stratum II: HER2-positive Experimental Treatment 6 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks.

Group III: Stratum I: HER2-negative Experimental Treatment 5 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks.

Group IV: Stratum C: HER2-negative Experimental Treatment 5 Interventions

Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. 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 V: Stratum B: HER2-negative Experimental Treatment 5 Interventions

Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A.

Group VI: Stratum A: HER2-positive Experimental Treatment 6 Interventions

Patients receive Paclitaxel 80 mg/m\^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m\^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion 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:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in European Union as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+