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

Use our guide to learn which trials are right for you!

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
sites
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
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...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
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...
?
mi
from
Augusta, ME
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
?
mi
from
Burlington, VT
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
?
mi
from
Macon, GA
Click here to add this to my saved trials
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
?
mi
from
Spokane, WA
Click here to add this to my saved trials
1 Akron General Avenue
Akron, Ohio 44307
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alton, Illinois 62002
?
mi
from
Alton, IL
Click here to add this to my saved trials
Anacortes, Washington 98221
?
mi
from
Anacortes, WA
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Attleboro, Massachusetts 02703
?
mi
from
Attleboro, MA
Click here to add this to my saved trials
Auburn, Washington 98001
?
mi
from
Auburn, WA
Click here to add this to my saved trials
1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austell, Georgia 30106
?
mi
from
Austell, GA
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Beech Grove, Indiana 46107
?
mi
from
Beech Grove, IN
Click here to add this to my saved trials
Bellingham, Washington 98225
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
?
mi
from
Berlin, VT
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
?
mi
from
Billings, MT
Click here to add this to my saved trials
900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
?
mi
from
Boston, MA
Click here to add this to my saved trials
1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
?
mi
from
Boulder, CO
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Bremerton, WA
Click here to add this to my saved trials
Brighton, Massachusetts 02135
?
mi
from
Brighton, MA
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Burien, Washington 98166
?
mi
from
Burien, WA
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
?
mi
from
Canton, OH
Click here to add this to my saved trials
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...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
Cape Girardeau, Missouri 63701
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
20055 Lake Chabot Rd #130
Castro Valley, California 94546
(510) 888-0657
Valley Medical Oncology Consultants - Castro Valley Valley Medical Oncology Consultants (VMOC) has been helping...
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
Castro Valley, California 94546
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
Centralia, Washington 98531
?
mi
from
Centralia, WA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29401
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60608
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60631
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60640
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Clive, IA
Click here to add this to my saved trials
6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, New Hampshire 03301
?
mi
from
Concord, NH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
?
mi
from
Danville, VA
Click here to add this to my saved trials
2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45415
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Dearborn, Michigan 48124
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
?
mi
from
Denver, CO
Click here to add this to my saved trials
4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Des Moines, Iowa 50307
?
mi
from
Des Moines, IA
Click here to add this to my saved trials