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A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

This Phase III, randomized, open-label trial will determine whether the regimens of
chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS)
relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include
determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will
improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI),
and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS,
DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens.
The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated.

Following local determination that the tumor is HER2-positive for gene amplification by in
situ hybridization or is IHC 2+ or 3+, a tumor sample must be submitted for HER2 testing by
a designated central laboratory. If central testing confirms that the tumor is
HER2-positive (either positive by FISH or IHC 3+) and all other eligibility criteria have
been met, the patient will be randomized to a regimen of chemotherapy and trastuzumab with
or without bevacizumab.

Patients in the trial will be enrolled in one of two chemotherapy regimen cohorts. One
cohort will receive 6 cycles of docetaxel/carboplatin plus trastuzumab (TCH) with or without
bevacizumab; the other cohort will receive 3 cycles of docetaxel plus trastuzumab given with
or without bevacizumab followed by 3 cycles of 5-Fluorouracil, Epirubicin, Cyclophosphamide
(TH-FEC). With both regimens, patients will continue trastuzumab with or without
bevacizumab following chemotherapy to complete 1 year of targeted therapy. Following
completion of chemotherapy, patients will also receive adjuvant radiotherapy and endocrine
therapy as clinically indicated.

The trial will be conducted by investigators affiliated with the Cancer International
Research Group (CIRG) and the National Surgical Adjuvant Breast and Bowel Project (NSABP).
CIRG and NSABP investigators will only enroll patients in the TCH regimen cohort.
Additional investigators, referred to in the protocol as Independent Investigators, will
enroll patients in both the TCH regimen or the TH-FEC regimen cohort depending on
institutional preference for the one regimen that will be used by that institution for the
duration of the trial.

Patients will be given the option of allowing their tumor samples to be used for the BETH
translational research and correlative science studies. Also, patients will be asked to
consent to the submission of blood and serum samples at scheduled time points during the

LVEF assessments will be performed before study entry and then at scheduled time points
during therapy and at 18, 36, and 60 months following randomization.

The planned sample size for the trial is 3,000 patients randomized in the faster accruing
cohort and a minimum of 3,500 patients overall.

Inclusion Criteria:

- Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.

- Women who have had breast reconstruction utilizing tissue expanders must be in
agreement with delaying surgery to replace the tissue expanders with permanent
implants until 3 months following the last dose of bevacizumab

- Women of reproductive potential must agree to use an effective non-hormonal method of
contraception (for example condoms, some intrauterine devices, diaphragms,
vasectomized partner, or abstinence) during therapy and for at least 6 months after
the last dose of bevacizumab and/or trastuzumab.

- Submission of tumor samples from the breast surgery for central HER2 testing is
required for all patients prior to enrollment in the BETH Trial

- Signed and dated IRB/EC-approved consent

- ECOG performance status of 0 or 1

- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic

- The breast cancer must be HER2-positive based on test results as follows: Local
testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is
considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ
hybridization (ISH) method. If local ISH test results are considered equivocal, the
tumor can be submitted for central HER2 testing. (If local testing is not possible,
the tumor can be submitted for central HER2 testing.) Central testing (a requirement
for ALL patients) must demonstrate that the tumor is HER2-positive which is defined
as FISH-positive and/or IHC 3+.

- All of the following staging criteria (according to the 6th edition of the AJCC
Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be
pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a,
pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must
be met: Pathologic tumor size > 2.0 cm; ER negative and PgR negative; Histologic
and/or nuclear grade 2 (intermediate) or 3 (high); or Age < 35 years

- Patients must have undergone either a total mastectomy or breast conserving surgery

- For patients who undergo lumpectomy, the margins of the resected specimen must be
histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as
determined by the local pathologist. If pathologic examination demonstrates tumor at
the line of resection, additional operative procedures may be performed to obtain
clear margins. If tumor is still present at the resected margin after
re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients
with margins positive for lobular carcinoma in situ [LCIS] are eligible without
additional resection.)

- For patients who undergo mastectomy, margins must be free of gross residual tumor.
Patients with microscopic positive margins are eligible.

- Patients must have completed one of the following procedures for evaluation of
pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional
non-sentinel lymph nodes if the sentinel node (SN) is positive; Sentinel
lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy
is pN0, pN1mi or pN1b; or Axillary lymphadenectomy without SN isolation procedure.

- The interval between the last surgery for breast cancer (treatment or staging) and
randomization must be at least 28 days but no more than 84 days.

- Patients must have ER analysis performed on the primary tumor prior to randomization.
If ER analysis is negative, then PgR analysis must also be performed.

- The most recent postoperative blood counts, performed within 6 weeks prior to
randomization, must meet the following criteria: ANC must be greater than or equal to
1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; and Hemoglobin
must be greater than or equal to 10 g/dL.

- The following criteria for evidence of adequate hepatic function must be met based on
the results of the most recent postoperative tests performed within 6 weeks prior to
randomization: total bilirubin must be less than or equal to upper limit of normal
(ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due
to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST
must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and AST may
not both be > the ULN.

- Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the
study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months
prior to randomization) does not demonstrate metastatic disease and the requirements
for evidence of adequate hepatic function are met.

- Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN
are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan
(performed within 3 months prior to randomization) does not demonstrate metastatic

- The following criteria for renal function must be met based on the results of the
most recent postoperative tests performed within 6 weeks prior to randomization:
Serum creatinine must be less than or equal to ULN for the lab. Measured or
calculated creatinine clearance must be > 60 mL/min.

- A urine sample must be tested for protein by determination of the urine
protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be less than
1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is greater than
or equal to 2+, determine the UPC ratio, which must be less than 1.0, or collect a
24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.

- LVEF assessment must be performed within 3 months prior to randomization. The LVEF
must be greater than or equal to 55% regardless of the cardiac imaging facility's
lower limit of normal (LLN).

- The ECG (performed within 3 months prior to randomization) must not have demonstrated
any of the following conditions: ventricular arrhythmias except for benign premature
ventricular contractions; supraventricular and nodal arrhythmias requiring a
pacemaker or not controlled with medication; and conduction abnormality requiring a

Exclusion Criteria:

- Inflammatory breast cancer.

- Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging
[mandatory for all patients] and other imaging [if required] must have been performed
within 3 months prior to randomization.)

- Synchronous or previous contralateral invasive breast cancer (Patients with
synchronous or previous contralateral DCIS or LCIS are eligible).

- History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral
DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are

- History of non-breast malignancies within the 5 years prior to study entry, except
for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,
melanoma in situ, and basal cell and squamous cell carcinomas of the skin.

- Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or
bevacizumab for any malignancy.

- RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed
breast cancer prior to randomization.

- Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other
SERM) or an aromatase inhibitor. (Patients are eligible if these medications are
discontinued prior to randomization.)

- Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement
therapy, etc. Patients are eligible if these medications are discontinued prior to

- Cardiac disease (history of and/or active disease) that would preclude the use of the
drugs included in the treatment regimens. This includes but is not confined to:
Active cardiac disease - angina pectoris that requires the use of anti-anginal
medication; ventricular arrhythmias except for benign premature ventricular
contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not
controlled with medication; conduction abnormality requiring a pacemaker; valvular
disease with documented compromise in cardiac function; and symptomatic pericarditis.
History of cardiac disease - myocardial infarction documented by elevated cardiac
enzymes or persistent regional wall abnormalities on assessment of LV function;
history of documented CHF; and documented cardiomyopathy.

- Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or
diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be
assessed within 28 days prior to randomization.) Patients with initial BP elevations
are eligible if initiation or adjustment of BP medication lowers pressure to meet
entry criteria.

- History of hypertensive crisis or hypertensive encephalopathy.

- History of TIA or CVA.

- History of any arterial thrombotic event within 12 months before randomization.

- Symptomatic peripheral vascular disease.

- Intrinsic lung disease resulting in dyspnea.

- Unstable diabetes mellitus.

- Active infection or chronic infection requiring chronic suppressive antibiotics.

- Any significant bleeding within 6 months before randomization, exclusive of
menorrhagia in premenopausal women.

- Non-healing wound, skin ulcers, or incompletely healed bone fracture.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to planned start of study therapy.

- Anticipation of need for major surgical procedures during study therapy and for at
least 3 months following completion of bevacizumab.

- Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before

- History of GI perforation, abdominal fistulae, or intra-abdominal abscess.

- Known bleeding diathesis or coagulopathy.

- Requirement for therapeutic doses of coumadin or equivalent.

- Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI
CTCAE v3.0.

- Conditions that would prohibit administration of corticosteroids.

- Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone
equivalent) (excluding inhaled steroids).

- History of hypersensitivity reaction to drugs formulated with polysorbate 80.

- Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be
performed within 14 days prior to randomization according to institutional standards
for women of child-bearing potential.)

- Other non-malignant systemic disease that would preclude the patient from receiving
study treatment or would prevent required follow-up.

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements.

- Use of any investigational product within 4 weeks prior to enrollment in the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Invasive Disease-free Survival (IDFS)

Outcome Time Frame:

up to 10 years

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

December 2021

Related Keywords:

  • Breast Cancer
  • HER2 positive breast cancer
  • invasive breast cancer
  • bevacizumab
  • Roche
  • CIRG
  • trastuzumab
  • cyclophosphamide
  • docetaxel
  • carboplatin
  • 5-fluorouracil
  • epirubicin
  • Breast Neoplasms



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Michiana Hematology-Oncology, P.C. Cedar St. South Bend, Indiana  46617
Hematology and Medical Oncology Consultants-Bettendorf Bettendorf, Iowa  52722
Hematology and Medical Oncology Consultants-Davenport Davenport, Iowa  52804
NortonHealthcare Pavillion Louisville, Kentucky  40202
Norton Medical Plaza II Louisville, Kentucky  40207
Norton Medical Plaza West Louisville, Kentucky  40217
Old Brownsboro Crossing Louisville, Kentucky  40241
Harry & Jeannette Weinberg Cancer Institute Baltimore, Maryland  21237
Hematology-Oncology Associates Baltimore, Maryland  21237
Carolyn Hendricks, MD Bethesda, Maryland  20817
Washington Oncology-Hematology Center, PC-Chevy Chase Chevy Chase, Maryland  20815
The Office of Frederik Smith Chevy Chase, Maryland  20815
Peninsula Regional Oncology & Hematology Salisbury, Maryland  20817
Berkshire Hematology Oncology, P.C.-North Adams North Adams, Massachusetts  01247
CCOP, St. Joseph Mercy Hospital Ann Arbor, Michigan  48106
Dr. Cook and Abramson - Bay City Bay City, Michigan  48706
St. Joseph Mercy Woodland Health Center Brighton, Michigan  48114
Josephone Ford Cancer Center Brownstown, Michigan  48183
UP Hematology/Oncology Assoc.-Doctor's Park Family Physicians Escanaba, Michigan  49829
Sing and Arora Flint, Michigan  48532
Genesys Hurley Flint, Michigan  48503
CCOP Hurley Medical Center Flint, Michigan  48503
St. Mary's Health Services Grand Rapids, Michigan  49503
CCOP, St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  19229
Portage Internal Medical Associates Hancock, Michigan  49935
UP Hematology/Oncology Associates Iron Mountain, Michigan  49801
UP Hematology/Oncology Associates-Gogebic Range Ironwood, Michigan  49938
Hematology/Oncology Associates of OH and MI, PC Lambertville, Michigan  48144
CCOP, Sparrow Health System Lansing, Michigan  48909
Hematology Oncology-Lapeer Lapeer, Michigan  48446
Keewanaw Memorial Hospital Laurium, Michigan  49913
St. Mary Mercy Hospital - Livonia Livonia, Michigan  48154
Upper Peninsula Hematology/Oncology Associates Marquette, Michigan  49855
Community Cancer Care Specialists-Mt. Clemens Mt. Clemens, Michigan  48043
Michiana Hematology-Oncology PC Niles, Michigan  49120
CCOP, St. Mary's Medical Center Saginaw, Michigan  48601
Chippewa Medical Associates Sault Saint Marie, Michigan  49783
Osteopathic Medical Oncology Hematology Shelby Township, Michigan  48315
Michiana Hematology-Oncology, PC Lakeland St. Joseph, Michigan  49085
CCOP, St. John Macomb Hospital Warren, Michigan  48093
Minnesota Oncology Hematology-Burnsville Burnsville, Minnesota  55337
Hubert H. Humphrey Cancer Center - Coon Rapids Coon Rapids, Minnesota  55433
Minnesota Oncology Hematology-Edina Edina, Minnesota  55435
Fairview Southdale Medical Oncology Clinic Edina, Minnesota  55455
Hubert H. Humphrey Cancer Center - Fridley Fridley, Minnesota  55432
Minnesota Oncology Hematology PA - Maplewood Maplewood, Minnesota  55109
Minnesota Oncology Hematology-Minneapolis Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center-Robbinsdale Robbinsdale, Minnesota  55422
Minnesota Hematology Oncology-St. Paul St. Paul, Minnesota  55102
Minnesota Oncology Hematology-Waconia Waconia, Minnesota  55387
University of Tennessee Cancer Institute Southaven, Mississippi  38671
St. John's Regional Health Center-Joplin Joplin, Missouri  64804
Cox Health Systems Springfield, Missouri  65807
Comprehensive Cancer Centers of Nevada (Siena) Henderson, Nevada  89052
Cancer Consultants Las Vegas, Nevada  89106
Cancer and Blood Specialists- Shadow Lane Las Vegas, Nevada  89106
Alpine Hematology-Oncology Reno, Nevada  89503
NY Oncology Hematology PC at Albany Medical Center Albany, New York  12208
Hematology Oncology Assaociates of CNY, CCOP East Syracuse, New York  12010
NY Oncology Hematology PC-Hudson Carvell Cancer Tx Prog. Hudson, New York  12534
NY Oncology Hematology PC- Latham- Capital District Oncology Hematology Latham, New York  12110
Riverview Cancer Care Medical Association Rexford, New York  12148
Hematology Oncology Associates of CNY, CCOP Rome, New York  13440
University Hospital and Medical Center-SUNY Stony Brook, New York  11794
Hematology Oncology Assoc. of CNY, CCOP (Comm. General Hospital Satellite Office) Syracuse, New York  13215
Troy Cancer Treatment Program Troy, New York  12180
Cancer Center of NC at Asheville Asheville, North Carolina  28803
CCOP, Mission Hospitals, Inc. Asheville, North Carolina  28801
Carolinas Hematology-Oncology Associates - Tyron St Charlotte, North Carolina  28203
CCOP Presbyterian Hospital Charlotte, North Carolina  28204
Carolinas Medical Center - Blumenthal Cancer Center Charlotte, North Carolina  28204
Carolinas Hematology Oncology Associates - Harris Blvd. Charlotte, North Carolina  28262
Carolinas Hematology-Oncology - John J. Delaney Charlotte, North Carolina  28277
Mecklenburg Medical Group - Cameron Valley Pkwy Charlotte, North Carolina  28211
Mecklenburg Medical Group - Morehead Medical Dr Charlotte, North Carolina  28204
CCOP, Wayne Memorial Hospital Goldsboro, North Carolina  27534
Alliance Cancer Center Alliance, Ohio  44601
Tri County Hematology/Oncology Canton, Ohio  44781
Kenwood Office Cincinnati, Ohio  45236
North Treatment Center - Blue Ash Medical Center Cincinnati, Ohio  45242
Oncology/Hematology Care Clinical Trials LLC, Cincinnati, OH Blue Ash Med. Cntr. (Administrative Only) Cincinnati, Ohio  45242
Oncology/Hematology Care Clinical Trials LLC Cincinnati, Ohio  45236
Dayton Physicians-LLC-Hematology & Medical Oncology Division Dayton, Ohio  45415
Healthplex Fairfield, Ohio  45014
Dayton Physicians, LLC - Greenville Greenville, Ohio  45331
Hamilton Office Hamilton, Ohio  45013
Dayton Clinical Oncology Program-Kettering Kettering, Ohio  45429
Marian A. Llenado Lee, MD, Inc. Kettering, Ohio  45429
UHHS - Chagrin Highlands Orange Village, Ohio  44122
UHHS Green Road-Ireland Cancer Center South Euclid, Ohio  44121
UHHS Westlake-Ireland Cancer Center Westlake, Ohio  44145
Northwest Cancer Specialists-Adventist Office Portland, Oregon  97216
Northwest Cancer Specialists-Portland Portland, Oregon  97213
Providence Oncology and Hematology Care Clinic Portland, Oregon  97225
Hematology Oncology Associates of NE PA Donora, Pennsylvania  18142
UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview Greensburg, Pennsylvania  15601
UPMC Cancer Centers Arnold Palmer-Oakbrook Greensburg, Pennsylvania  15601
UPMC Cancer Centers-Indiana Indiana, Pennsylvania  15701
UPMC Cancer Centers-John P. Murtha Cancer Center Johnstown, Pennsylvania  15901
UPMC Cancer Centers - McKeesport Hospital McKeesport, Pennsylvania  15132
UPMC Cancer Centers Arnold Palmer-Mt. Pleasant Mt. Pleasant, Pennsylvania  15666
Cancer Center at Center One Philadelphia, Pennsylvania  19115
UPMC Cancer Centers - UPMC Passavant PIttsburgh, Pennsylvania  15237
UPMC Cancer Centers - UPMC St. Margaret Pittsburgh, Pennsylvania  15215
NSABP Foundation, Inc Pittsburgh, Pennsylvania  15212
UPMC Cancer Centers-Uniontown Uniontown, Pennsylvania  15401
UPMC Cancer Centers - Wexford Wexford, Pennsylvania  15090
Thompson Oncology Group-West Knoxville, Tennessee  37932
Thompson Oncology Group-Blount Knoxville, Tennessee  37804
Texas Oncology- Sammons CC Dallas, Texas  75246
Covenant Health System dba Joe Arrington Cancer Research & Treatment Center Lubbock, Texas  79410
McKay-Dee Hospital Ogden, Utah  84403
Dixie Medical Center St. George, Utah  84780
VCU Massey Cancer Center at Stony Point Richmond, Virginia  23235
Overlake Internal Medicine Bellevue, Washington  98004
Rockwood Cancer Treatment Center - Sinto Ave Spokane, Washington  99204
Northwest Cancer Specialists-136th Ave Vancouver, Washington  98684
Northwest Cancer Specialists-134th St. Vancouver, Washington  98686
Southwest Washington Hospital Vancouver, Washington  98664
Oncology Alliance-Burlington Burlington, Wisconsin  53105
Oncology Alliance-Franklin Franklin, Wisconsin  53132
Oncology Alliance-Kenosha North Kenosha, Wisconsin  53144
Oncology Alliance-Kenosha South Kenosha, Wisconsin  53143
Oncology Alliance-Menomonee Falls Menomonee Falls, Wisconsin  53051
Oncology Alliance-Mequon Mequon, Wisconsin  53092
Oncology Alliance-South Milwaukee, Wisconsin  53215
Oncology Alliance-Racine Racine, Wisconsin  53406
Oncology Alliance-Waukeska Waukesha, Wisconsin  53188