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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5805 Monclova Rd
Maumee, Ohio 43537
(419) 891-5600
Northwest Ohio Oncology Center The Northwest Ohio Oncology Center, located on the campus of ProMedica...
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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
(605) 322-4700
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
(316) 261-3200
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
517-265-0900
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
(317) 528-5000
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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Billings, Montana 59107
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2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
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
Billings, Montana 59101
(406) 237-3585
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
(701) 222-6100
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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720 E Rosser Ave
Bismarck, North Dakota 58501
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Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
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900 E Broadway Ave
Bismarck, North Dakota 58501
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
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
419-352-9498
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
Burnsville, Minnesota 55337
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400 S Clark St
Butte, Montana 59701
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St. James Healthcare Cancer Care The St. James Cancer Center is an integrated cancer treatment...
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701 10th St SE
Cedar Rapids, Iowa 52403
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Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
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525 10th St SE
Cedar Rapids, Iowa 52403
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Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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505 S Plummer Ave
Chanute, Kansas 66720
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
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Dayton, Ohio 45406
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1 Wyoming St
Dayton, Ohio 45409
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405 W Grand Ave
Dayton, Ohio 45405
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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9000 North Main Street
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
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1221 Pleasant St
Des Moines, Iowa 50309
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John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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411 Laurel St New Visions
Des Moines, Iowa 50314
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Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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411 Laurel Street
Des Moines, Iowa 50314
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Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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2020 Central Ave
Dodge City, Kansas 67801
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Duluth, Minnesota 55805
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
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502 E 2nd St,
Duluth, Minnesota 55805
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6401 France Ave S
Edina, Minnesota 55435
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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700 West Central
El Dorado, Kansas 67042
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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6282 Linton Blvd
Elyria, Ohio 44035
(561) 495-8307
Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Fort Scott, Kansas 66701
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105 Mcknight Drive
Franklin, Ohio 45005
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
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Great Falls, Montana 59405
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835 Sweitzer St
Greenville, Ohio 45331
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30 13th St
Havre, Montana 59501
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2475 Broadway St
Helena, Montana 59601
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800 W. Laurel
Independence, Kansas 67301
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Jacksonville, Florida 32216
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75 Claremont St Ste E
Kalispell, Montana 59901
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310 Sunnyview Lane
Kalispell, Montana 59901
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310 Sunnyview Ln
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750 Avenue D West
Kingman, Kansas 67068
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Kokomo, Indiana 46904
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1007 LINCOLNWAY
La Porte, Indiana 46350
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325 Maine Street
Lawrence, Kansas 66044
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1001 Bellefontaine Ave
Lima, Ohio 45804
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4600 Valley Rd # 336
Lincoln, Nebraska 68510
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Maplewood, Minnesota 55109
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
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500 W Broadway St
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500 John Deere Road
Moline, Illinois 61265
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800 Stewart Rd
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720 Medical Center Drive
Newton, Kansas 67114
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6901 N 72nd St
Omaha, Nebraska 68122
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7500 Mercy Rd
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601 N 30th St
Omaha, Nebraska 68131
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Oregon, Ohio 43616
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1902 S. US Hwy 59
Parsons, Kansas 67357
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124 Commodore, Ste. A
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1100 Reid Pkwy
Richmond, Indiana 47374
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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Saint Louis Park, Minnesota 55416
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3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
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333 Smith Ave
Saint Paul, Minnesota 55102
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600 S Santa Fe Ave
Salina, Kansas 67401
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