Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:February 2009

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Phase II Safety Study of Docetaxel and Carboplatin in Combination With Trastuzumab and Lapatinib in Early Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 docetaxel together
with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with
carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.

OBJECTIVES:

Primary

- Determine the safety and tolerability (including the rate of diarrhea) of adjuvant
therapy comprising docetaxel, carboplatin, trastuzumab (Herceptin®), and lapatinib
ditosylate in patients with early-stage breast cancer.

Secondary

- Evaluate the adverse event profile of this regimen in these patients.

- Evaluate LVEF in patients receiving this regimen.

OUTLINE: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on
day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral
lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6
courses in the absence of disease progression or unacceptable toxicity. Patients then receive
trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days
1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the
absence of disease progression or unacceptable toxicity..

After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 8 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the
following criteria:

- Nonmetastatic disease

- Operable and adequately excised

- Patients with nonresectable deep margin invasion are eligible provided they
have had or will receive radiotherapy to the region

- Patients with histologically documented infiltration of the skin (pT4) are
eligible provided they have undergone or will receive radiotherapy
encompassing the tumor bed

- Node-positive OR -negative and determined eligible to receive adjuvant
trastuzumab (Herceptin®)

- No positive or suspicious internal mammary nodes by SNS that have not been or will not
be irradiated

- No supraclavicular lymph node involvement (confirmed by fine needle aspiration or
biopsy)

- Over expression and/or amplification of HER2 in the invasive component of the primary
tumor, according to one of the following:

- 3+ over-expression by IHC (> 30% of invasive tumor cells)

- 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ
hybridization (FISH/CISH) test demonstrating HER2 gene amplification

- HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH
ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)

- Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0
HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in
30% or less neoplastic cells) by IHC not allowed

- Hormone receptor status known (estrogen receptor with or without progesterone
receptor)

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0-1

- Hemoglobin ≥ 10.0 g/dL

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 2.0 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)

- Baseline LVEF ≥ 50% measured by ECHO or MUGA scan

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serious cardiac illness or medical condition including, but not limited to, any of
the following:

- History of documented congestive heart failure (any NYHA class) or systolic
dysfunction (LVEF < 50%)

- High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade
atrioventricular-block [second degree or higher], or supraventricular arrhythmias
that are not adequately rate-controlled)

- Angina pectoris requiring antianginal medication

- Clinically significant valvular heart disease

- Evidence of transmural infarction on ECG

- Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or
diastolic BP > 100 mm Hg)

- No other concurrent serious diseases that may interfere with planned treatment
including severe pulmonary conditions or illness

- None of the following:

- Ulcerative colitis

- Malabsorption syndrome

- Any disease significantly affecting gastrointestinal function

- Inability to swallow oral medication

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior mediastinal irradiation except internal mammary-node irradiation for the
present breast cancer

- No prior anti-HER2 therapy for any reason

- No prior biologic or immunotherapy for breast cancer

- No prior resection of the stomach or small bowel

- No other concurrent anticancer therapy including chemotherapeutic agents, biologic
agents, or radiotherapy

- No concurrent anticancer treatment in another investigational trial with hormone
therapy or immunotherapy unless approved by the study chair

- No concurrent CYP3A4 inhibitors or inducers

- No concurrent epoetin alfa, including darbepoetin alfa

- No concurrent oprelvekin
We found this trial at
136
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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825 N Emporia Ave
Wichita, Kansas 67214
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Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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777 Kimole Ln
Adrian, Michigan 49221
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Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
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St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
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Billings, Montana 59101
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2900 12th Ave N Ste 160W
Billings, Montana 59101
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Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
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1101 N 27th St # 201
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St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
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500 N 8th St
Bismarck, North Dakota 58501
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Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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720 E Rosser Ave
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Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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900 East Broadway
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St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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960 W. Wooster
Bowling Green, Ohio 43402
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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931 Highland Blvd
Bozeman, Montana 59715
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201 E Nicollet Blvd
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525 10th St SE
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9000 North Main Street
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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1221 Pleasant St
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2020 Central Ave
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502 E 2nd St,
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700 West Central
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2315 E Harmony Rd #110
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1007 LINCOLNWAY
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800 E 28th St
Minneapolis, Minnesota 55407
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1902 S. US Hwy 59
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