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

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)

doxorubicin, cyclophosphamide, paclitaxel, trastuzumab

PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)

PLD, cyclophosphamide, trastuzumab, paclitaxel

The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.

Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)

Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy in Patients With HER2-positive Breast Cancer: Caelyx + Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), Each Followed by Paclitaxel + Trastuzumab (T+H) BACH

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Cardiac events defined as:

Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF

Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.

Relapse-free survival would have been determined by Kaplan-Meier method.

This was not calculated, since the 2 year follow-up was curtailed.

Merck Sharp & Dohme LLC

PLD Based Regimen

Doxorubicin Based Regimen

Pegylated Liposomal Doxorubicin (PLD) Based Regimen

doxorubicin 60 mg/m\^2 intravenous (IV) push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)

Total

Age information was for the intent-to-treat (ITT) population (n=59 for doxorubicin arm, n=120 for PLD arm). ITT was defined as all participants who were randomized and received at least 1 dose of any study medication.

Age, Continuous

Sex: Female, Male

Any follow-up data from this study should be considered with caution as the planned 2-year follow-up was curtailed because of administrative reasons.

Senior Vice President, Global Clinical Development

ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.

Each participant could not contribute more than 1 event.

Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year

Level 1 Cardiotoxicity

Level 2 Cardiotoxicity

Inability to Administer Trastuzumab

ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.

Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy

Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy

Number of Participants Who Survived Without Relapse

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)	NCT00550771	Breast Neoplasm	doxorubicin, cy... PLD, cyclophosp...	18 Years -	Merck Sharp & Dohme LLC
Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)	NCT00550771	Breast Neoplasm	doxorubicin, cy... PLD, cyclophosp...	18 Years -	Merck Sharp & Dohme LLC

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