Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Fluorouracil

Cyclophosphamide

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).

First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)

For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).

For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).

Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).

Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

5-fluorouracil

Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).

Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

Lajos Pusztai, MD

The main goal of this clinical trial is to test if adding pertuzumab (Perjeta), improves the anticancer activity of the combination chemotherapy regimen of trastuzumab (Herceptin) concomitant with paclitaxel, 5-fluorouracil, epirubicin, and cyclophosphamide (T-FEC). The study will also test the safety of this therapy.

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.

Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer

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.

To assess the safety of the regimen, cardiac safety was measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF \>10%, and decrease of LVEF below normal level. This was assessed up to 1 year following surgery.

To assess clinical response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the number of patients are presented with a clinical response.

To assess cancer burben, the Residual Cancer Burden (RCB) score was used. This score has a range of 0 - III, where III (3) is the worst level of burden.

Genentech, Inc.

Yale University

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.

This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).

During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).

Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)

Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).

For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).

Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).

5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).

Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).

Chemo Plus Pertuzumab,Trastuzumab

Age, Continuous

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Receptor status retrieved from the subjects diagnostic pathology report.

Hormone receptor status

Fluorescence in situ hybridization (FISH) and Immunohistochemistry (IHC) are tests used to detect breast cancer genetically. A positive FISH test and ICH status of 3+ are markers of HER2 status. These data were retrieved from the subjects' diagnostic pathology report and demonstrate the manner in which these patients were diagnosed.

HER2 status

Clinical Tumor Status

The type of surgery describes the manner in which the patients' breast cancer was addressed surgically.

Type of surgery

Lajos Pusztai, MD, DPhil

HR Positive

HR Negative

For ER-negative cancers, the maximum sample size was set to n = 25 and the regimen would be considered of interest if \> 20 patients achieve pCR. For ER-positive patients, the maximum sample size for the ER-positive cohort was set to 39 and the regimen would be considered of interest in this subgroup if \> 23 patients achieve pCR.

Spots Global Cancer Trial Database for Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

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