Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
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ClinicalTrials.gov Identifier: NCT00482391 |
Recruitment Status
:
Completed
First Posted
: June 5, 2007
Results First Posted
: March 13, 2017
Last Update Posted
: May 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Other: laboratory biomarker analysis | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Dose-Dense Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/NEU-Overexpressed/Amplified Breast Cancer: Feasibility |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB
The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
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Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Other: laboratory biomarker analysis |
- Number of Patients Who Completed All Planned Therapy [ Time Frame: 2 years ]The number of patients who completed all planned therapy (dose-dense adjuvant/ neoadjuvant chemotherapy regimen) in HER-2/neu-overexpressed/ amplified breast cancer patients.
- Number of Patients Who Were Evaluated for Toxicity [ Time Frame: 2 years ]Please see adverse event section in the results. Toxicities were assessed by the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0.

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed adenocarcinoma of the breast
- Bilateral synchronous breast tumors allowed
-
Any nodal status or tumor size allowed
- No stage IV disease
-
HER2/neu-positive disease
- 3+ by IHC OR FISH-amplified
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.1 mg/dL
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and after completion of study therapy
- LVEF ≥ 50% by MUGA scan
- No peripheral neuropathy > grade 1
- No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix
- No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL
- No psychiatric illness or concurrent medical conditions that would preclude study treatment
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No other conditions, including any of the following:
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past 12 months
- High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)
- No QT prolongation (> 500 ms)
- No active unresolved infections
- No sensitivity to E. coli derived proteins
PRIOR CONCURRENT THERAPY:
- Prior hormonal therapy for chemoprevention allowed
- No prior trastuzumab (Herceptin®)
- No prior anthracyclines
- No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)
- No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer
- No concurrent drugs that may prolong the QT

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): NCT00482391
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Chau T. Dang, MD | Memorial Sloan Kettering Cancer Center | |
Principal Investigator: | Clifford A. Hudis, MD | Memorial Sloan Kettering Cancer Center |
Publications of Results:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00482391 History of Changes |
Other Study ID Numbers: |
07-013 MSKCC-07013 |
First Posted: | June 5, 2007 Key Record Dates |
Results First Posted: | March 13, 2017 |
Last Update Posted: | May 12, 2017 |
Last Verified: | April 2017 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Liposomal doxorubicin Lapatinib Albumin-Bound Paclitaxel Cyclophosphamide Doxorubicin Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Protein Kinase Inhibitors |