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SINGLE ARM, NEOADJUVANT, PHASE II TRIAL OF PERTUZUMAB AND TRASTUZUMAB ADMINISTERED CONCOMITANTLY WITH WEEKLY PACLITAXEL AND FEC FOR CLINICAL STAGE I-III HER2-POSITIVE BREAST CANCER


Phase 2
18 Years
65 Years
Not Enrolling
Both
Her2-Positive Breast Cancer

Thank you

Trial Information

SINGLE ARM, NEOADJUVANT, PHASE II TRIAL OF PERTUZUMAB AND TRASTUZUMAB ADMINISTERED CONCOMITANTLY WITH WEEKLY PACLITAXEL AND FEC FOR CLINICAL STAGE I-III HER2-POSITIVE BREAST CANCER


Subjects will receive 6 months of T-FEC chemotherapy concomitant with trastuzumab and
pertuzumab before surgery. Subsequently, subjects will undergo surgery to remove any cancer
from the breast and axillary lymph nodes that may have survived the chemotherapy. It is
expected that the majority of women will have no viable cancer left in the breast or lymph
nodes by the time all chemotherapy is completed.


Inclusion Criteria:



- Patients with histologically confirmed stage I-III, HER2-positive invasive breast cancer
for which adjuvant/neoadjuvant chemotherapy is indicated based on physician judgment
following NCCN practice guidelines.

HER2 overexpression or amplification will be based on local test results and is defined as
either:

(i) IHC staining of 3+ (uniform, intense membrane staining) in greater than or equal to
10% of invasive tumor cells or, (ii) Fluorescent in situ hybridization (FISH) result of
more than six HER2 gene copies per nucleus or, (iii) FISH ratio (HER2 gene signals to
chromosome 17 signals) of greater than or equal to 2.0.

- Patients with synchronous bilateral breast cancers are eligible if at least one of
the tumors is HER2-positive.

- Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as
determined by either ECHO or MUGA, or within the institution's normal limits.

- Women of childbearing potential must have a negative pregnancy test (serum or urine
beta HCG) prior to initiation of chemotherapy. Both female and male breast cancer
patients who are sexually active have to agree to practice contraception while
participating in the trial and for 3 month after completion of therapy.

- Adequate bone marrow function as indicated by the following:

- ANC greater than or equal to 1500/uL

- Platelets greater than or equal to 100,000/uL

- Hemoglobin greater than or equal to 10 g/dL

- Adequate renal function, as indicated by creatinine less than or equal to 1.5 times
upper limit of normal (ULN)

- Adequate liver function, as indicated by bilirubin less than or equal to 1.5 X ULN
and AST or ALT less than or equal to 2x ULN.

- Signed informed consent.

Exclusion Criteria:

Patients will be excluded from the study based on any of the following criteria:

- Patients who underwent partial excisional biopsy, lumpectomy, segmental mastectomy,
modified radical mastectomy or sentinel node biopsy and, therefore cannot be assessed
for pathologic response accurately.

- Patients who are high risk for developing the following anthracycline, paclitaxel,
trastuzumab or pertuzumab related toxicities including:

History of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled
hypertension despite adequate medications Pre-existing peripheral neuropathy > grade 3
Prior anthracycline therapy Known hypersensitivity to any of the study medications
Patients older than age 65 due to increased risk of cardiotoxicity

- Active infection requiring systemic antibiotic therapy.

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Outcome Description:

To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Lajos Pusztai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

SC1303BRE001

NCT ID:

NCT01855828

Start Date:

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Breast Neoplasms

Name

Location

Yale UniversityNew Haven, Connecticut  06520