Chemotherapy + HER2-Targeted Therapy With or Without Hormone Therapy for Breast Cancer

Recruiting at 808 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

315 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer that is operable or has spread from where it started to nearby tissue or lymph nodes (locally advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

Research Team

Mothaffar F Rimawi

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with hormone receptor-positive, HER2-positive breast cancer that's operable or locally advanced. They should have a life expectancy over 10 years (excluding their diagnosis), normal organ function tests, and no history of certain treatments or conditions like previous malignancies within 5 years. Women must agree to non-hormonal contraception during and post-treatment.

Inclusion Criteria

Your AST blood test results must be within a certain range.

You are expected to live for at least 10 years, not counting your breast cancer diagnosis.

The patient should have good physical ability, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

You have already received radiation, chemotherapy, targeted therapy, or hormone therapy for your current breast cancer before joining the study.

Surgical axillary staging procedure prior to randomization

Excisional biopsy or lumpectomy performed prior to randomization

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab with or without estrogen deprivation every 21 days for up to 6 courses

18 weeks

6 visits (in-person)

Surgery

Patients undergo lumpectomy or mastectomy

1 day

1 visit (in-person)

Radiation

Patients undergo whole breast irradiation within 8 weeks following surgery

8 weeks

Adjuvant Treatment

Patients receive trastuzumab IV every 21 days for up to 1 year

1 year

17 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 6, 9, 12, and 18 months

Treatment Details

Interventions

• Aromatase Inhibition Therapy
• Carboplatin
• Docetaxel
• Goserelin Acetate
• Pertuzumab
• Therapeutic Conventional Surgery
• Trastuzumab
• Whole Breast Irradiation

Trial Overview The study compares the effectiveness of chemotherapy drugs (docetaxel, carboplatin) combined with targeted therapy (trastuzumab, pertuzumab) with or without estrogen deprivation using goserelin acetate and aromatase inhibitors in treating this type of breast cancer. It also includes radiation therapy and assesses quality-of-life impacts.

Participant Groups

Group I: Arm II (chemo, estrogen deprivation, surgery, radiation) Experimental Treatment 11 Interventions

NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.

Group II: Arm I (combination chemotherapy, surgery, radiation) Active Control 9 Interventions

NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.

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

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+