Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:December 1, 2008

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Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer

This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib
to see how well they work in treating patients with stage II or stage III breast cancer that
can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. 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 paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor
smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known
which regimen is more effective in treating patients with breast cancer.

PRIMARY OBJECTIVE:

I. To determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly
paclitaxel with trastuzumab plus lapatinib (THL) is 20% greater than the pCR to weekly
paclitaxel with trastuzumab alone (TH).

SECONDARY OBJECTIVES:

I. To determine the pathologic complete response in the breast and axilla, using American
Joint Committee on Cancer (AJCC) Tumor, Lymph Nodes and Metastasis (TMN) criteria (version
6), to neoadjuvant weekly paclitaxel plus human epidermal growth factor 2 (HER2)- targeted
therapy in patients with HER2-positive operable breast cancer.

II. To evaluate residual cancer burden (RCB) as a predictor of long term relapse free
survival (RFS) and overall survival (OS).

III. To document the toxicity of all chemotherapeutic regimens (THL, TH). IV. To determine
the correlation between clinical, radiographic and pathologic response.

V. To compare overall survival (OS), relapse free survival (RFS) and time to first failure
(TFF) among the treatment groups.

VI. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for
which biomarker data exist and to evaluate biomarkers in blood, serum and tissue that are
likely to influence response to and toxicity of trastuzumab alone or trastuzumab plus
lapatinib, when given with paclitaxel.

VII. To determine the surgical practice patterns for breast conservation and sentinel
lymphadenectomy in patients undergoing neoadjuvant chemotherapy.

VIII. To determine the radiotherapy practice patterns for post-mastectomy and regional nodal
irradiation in patients undergoing neoadjuvant chemotherapy.

IX. To evaluate pharmacogenomic determinants of toxicity.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive trastuzumab IV over 30-90 minutes and paclitaxel IV over 1 hour once
weekly and lapatinib ditosylate orally (PO) once daily for 16 weeks in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive trastuzumab and paclitaxel as in arm I.

ARM III: Patients receive paclitaxel and lapatinib ditosylate as in arm I. (Discontinued as
of 6-15-11) Within 42 days after completion of neoadjuvant therapy, patients in both arms
undergo definitive surgery (breast conservation or total mastectomy).

After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for up to 10 years.

Inclusion Criteria:

- Pathologic confirmation of invasive breast cancer; patients with inflammatory breast
cancer are not eligible

- Clinical stage II-III operable invasive breast cancer with intent to perform surgical
resection after neoadjuvant therapy

- Patients with multicentric or bilateral disease are eligible as long as the
target lesion meets the eligibility criteria for this study

- Staging to rule out metastatic disease is recommended for clinical stage III
patients

- Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or
gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2
on invasive tumor

- Estrogen receptor (ER) and progesterone receptor (PgR) status must be known

- The target lesion in the breast must be >= 1 cm on physical examination or by
radiographic measurement; palpable axillary adenopathy will be documented but not
serve as measurable disease for the primary endpoint; patients with axillary disease
only are not eligible to participate

- Patient agrees to provide pretreatment biopsies

- No prior chemotherapy, hormone therapy, biologic, or radiation therapy with
therapeutic intent for this cancer

- Cardiac ejection fraction must be >= 50% by echocardiogram or multiple gated
acquisition (MUGA) scan

- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

- Patients must not be pregnant or nursing

- Absolute neutrophil count (ANC) >= 1,000/ul

- Platelet count >= 100,000/ul

- Bilirubin =< 1.5 times upper limit of normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper
limit of normal (ULN)

- Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless
status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months);
assay must have a sensitivity of at least 50 mIU/mL
We found this trial at
318
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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800 Washington St
Boston, Massachusetts 02111
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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524 South Park Street
Kalamazoo, Michigan 49007
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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777 Hemlock Street
Macon, Georgia 31201
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300 Community Drive
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601 South Sherman Street
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1 Akron General Avenue
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1500 East Medical Center Drive
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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1968 Peachtree Rd NW
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489 State St
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900 E Broadway Ave
Bismarck, North Dakota 58501
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450 Brookline Ave
Boston, Massachusetts 2215
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Boston, Massachusetts 02114
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1100 Balsam Ave
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915 Highland Blvd
Bozeman, Montana 59715
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
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20126 Stanton Ave
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1200 West Harrison Stree
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5841 S Maryland Ave
Chicago, Illinois 60637
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18101 Lorain Avenue
Cleveland, Ohio 44111
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Danville, Virginia 24541
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Dayton, Ohio 45406
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