T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

Description

This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2. The names of the study interventions involved in this study are: - Trastuzumab emtansine (also called T-DM1) - Pertuzumab

Study Start Date

December 2014

Estimated Completion Date

April 2022

Interventions

  • Procedure: Excision of tumor/mastectomy
  • Drug: Pertuzumab
  • Drug: T-DM1

Specialties

  • Oncology: Breast
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Breast Neoplasms
  • Pertuzumab

Study ID

Dana-Farber Cancer Institute -- 14-409

Status

Recruiting

Trial ID

NCT02326974

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

160

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 2 cm determined by physical exam or imaging is required.
  • HER-2 positive, confirmed by central testing (Clarient labs): IHC 3+ and/or FISH positive (HER2/CEP17 ?2) and/or HER2 gene amplification (> 6 HER2 gene copies per nucleus).
  • ER/PR determination is required.
  • Bilateral breast cancers are allowed if both cancers are HER2-positive.
  • Patients with multifocal or multicentric disease are eligible as long as one area meets eligibility criteria.
  • Breast imaging should include the ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes.
  • Men and women (with any menopausal status) ? 18 years of age
  • ECOG performance status 0 or 1
  • Required laboratory values:
  • ANC ?1500/mm3
  • Hemoglobin ? 9 g/dl
  • Platelets ?100,000/mm3
  • Serum creatinine < 1.5 X ULN (institutional)
  • Total bilirubin ? 1.0 X ULN (institutional) For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range.
  • AST and ALT ? 1.5x ULN (institutional)
  • Alkaline phosphatase ?1.5x ULN (institutional)
  • Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (HBcAb) in addition to HCV antibody testing.
  • Left ventricular ejection fraction (LVEF) ? 55%
  • Premenopausal women must have a negative serum pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.
  • Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment.
  • Potent CYP3A4 inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment period with T-DM1.
  • Excessive alcohol intake should be avoided (occasional use is permitted).
  • Patients with a history of ipsilateral DCIS are eligible.
  • Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
  • Willing and able to sign informed consent.
  • Willing to provide tissue for research purposes.

Exclusion Criteria

  • Pregnant or nursing women due to the teratogenic potential of the study drugs.
  • Active, unresolved infection.
  • Receipt of intravenous antibiotics for infection within 7 days prior to enrollment.
  • Patients with active liver disease, for example, due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis.
  • Uncontrolled hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring medication.
  • Significant symptoms (Grade ?2) peripheral neuropathy.
  • Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.
  • Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Steven Come MD 617-667-0982 scome@caregroup.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Ian Krop MD PhD 617-632-6973 IKROP@PARTNERS.ORG
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Aditya Bardia MD 617-643-2208 abardia1@partners.org
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles Ingrid Mayer MD None ingrid.mayer@vanderbilt.edu

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