T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
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
Estimated Completion Date
- Procedure: Excision of tumor/mastectomy
- Drug: Pertuzumab
- Drug: T-DM1
- Oncology: Breast
- Pharmacy: Chemotherapy/Oncology
- Physician Assistant: Hematology/Oncology
- Breast Neoplasms
Dana-Farber Cancer Institute -- 14-409
Dana-Farber Cancer Institute
- 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.
- 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.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (4)
|Beth Israel Deaconess Medical Center - Boston, Massachusetts||2.4 miles||Steven Come MDemail@example.com|
|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 MDfirstname.lastname@example.org|
|VanderbiltIngram Cancer Center - Nashville, Tennessee||944.2 miles||Ingrid Mayer MD||Noneemail@example.com|