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.
Principal Investigator
Kate Lathrop
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Kate Lathrop
(210) 450-1420
lathrop@uthscsa.edu
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Staff
regaffstaff@uthscsa.edu
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
| Arm | Description | Intervention |
|---|---|---|
Arm II (chemo, estrogen deprivation, surgery, radiation) | 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. | Given at the investigator's discretion Other names:
Undergo 2 core biopsies Other names:
Given SC Other names:
Given IV Other names:
Undergo lumpectomy or mastectomy Undergo whole breast irradiation Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
|
Arm I (combination chemotherapy, surgery, radiation) | 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. | Undergo 2 core biopsies Other names:
Given IV Other names:
Undergo lumpectomy or mastectomy Undergo whole breast irradiation Given IV Other names:
Given IV Other names:
Correlative studies Ancillary studies Other names:
Given IV Other names:
|