A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

Conditions

• Invasive Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• doxorubicin — DRUG
  60 mg/m2 IV every 21 days for cycles 1-4
• cyclophosphamide — DRUG
  600 mg/m2 IV every 21 days for cycles 1-4
• paclitaxel — DRUG
  80 mg/m2 IV on days 1, 8, and 15 every 28 days for cycles 5-8
• trastuzumab — DRUG
  First dose: 4 mg/kg IV, subsequent doses: 2 mg/kg IV weekly beginning on day 1 of the first paclitaxel cycle until 1-7 days before surgery
• lapatinib — DRUG
  Group 2: 1250 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery. Group 3: 750 mg PO daily beginning on day 1 of the first paclitaxel cycle until 1 day before surgery.

Study Details

The primary purpose of this study is to determine whether breast cancer tumors respond (as measured by pathologic complete response: the absence of microscopic evidence of invasive tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide) followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients with HER2-positive breast cancer. Trastuzumab will also be given to all patients after surgery. The study will also evaluate the toxic effects of the chemotherapy combination, including effects on the heart, and will determine survival and progression-free survival 5 years after treatment. Also, the study will look at whether there are gene expression profiles in the tumor tissue that can predict pathologic complete response.

Key Dates

Start date

Jul 31, 2007

Status verified

Jun 2016

Primary completion

Jun 30, 2012

Completion

Mar 31, 2017

Study Design

Enrollment

529 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1: AC then paclitaxel + trastuzumab
  AC followed by paclitaxel plus trastuzumab
• Experimental: Group 2: AC then paclitaxel + lapatinib
  AC followed by paclitaxel plus lapatinib
• Experimental: Group 3: AC then paclitaxel + trastuzumab + lapatinib
  AC followed by paclitaxel plus trastuzumab plus lapatinib

Primary Outcome Measure

Determination of pathologic complete response (pCR), defined by the absence of microscopic evidence of invasive tumor cells in the post chemotherapy surgical breast specimen. [ Time Frame: surgery following chemotherapy ]

Locations (103)

Find similar trials in Mobile, AL

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