Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00436566|
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : November 21, 2012
Last Update Posted : August 5, 2022
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cardiac Toxicity||Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: fluorophotometry Other: laboratory biomarker analysis Other: mass spectrometry Procedure: adjuvant therapy Procedure: quality-of-life assessment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer|
|Actual Study Start Date :||March 16, 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||July 22, 2019|
- Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment [ Time Frame: 6 months ]
- Adverse Event Profile as Measured by NCI CTCAE v 3.0 [ Time Frame: 5 years ]Measured by number of patients with at least one with grade 3+, Grade 4+, Hem, and Non-Hem AEs.
- Cumulative Incidence (CI) of Cardiac Events [ Time Frame: 5 years ]
Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.
Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)
- Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 5 years ]Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) from baseline to any post-baseline time point.
- Percentage of Participants With Disease-Free Survival (DFS) [ Time Frame: 5 years ]DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
- Percentage of Participants With Overall Survival (OS) [ Time Frame: 5 years ]OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
- Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL [ Time Frame: 5 years ]LASA score is from 0-90 with 0 being the worst and 90 being the best. SDS score is from 13-65 with 65 being the worst and 13 being the best.
- Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements [ Time Frame: 5 years ]Overall Symptom Distress Scale (SDS) QOL Measurement and Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) QOL Measurement
- Incidence of Pulmonary Events [ Time Frame: 5 years ]Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436566
|United States, Minnesota|
|Mayo Clinic Cancer Research Consortium|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Edith A. Perez, MD||Mayo Clinic|
|Principal Investigator:||Donald W. Northfeld, MD||Mayo Clinic|
|Principal Investigator:||James N. Ingle, MD||Mayo Clinic in Rochester|