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Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Triple-negative Breast Cancer

Thank you

Trial Information

Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer


I. To determine whether adding bevacizumab to neoadjuvant weekly paclitaxel (+/-
carboplatin) and subsequent dose-dense doxorubicin and cyclophosphamide (ddAC) significantly
raises the rate of pathologic complete response (pCR) in the breast in patients with
HR-poor/HER2 (-), resectable breast cancer.

II. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel
followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in
patients with HR-poor/HER2(-), resectable breast cancer.

III. To determine whether adding bevacizumab every 2 weeks to neoadjuvant weekly paclitaxel
(+/- carboplatin) and subsequent ddAC significantly raises the rate of pCR in the breast in
patients with basal-like breast cancers, as defined by gene expression array.

IV. To determine whether adding carboplatin every 3 weeks to neoadjuvant weekly paclitaxel
followed by ddAC (+/- bevacizumab) significantly raises the rate of pCR in the breast in
patients with basal-like breast cancers, as defined by gene expression array.


I. To determine the pCR rates in the breast and axilla, using AJCC TNM criteria (Version 6),
to neoadjuvant weekly paclitaxel, with or without carboplatin, followed by ddAC, with or
without bevacizumab, given concurrently with the weekly paclitaxel and ddAC, in (a) patients
with HR-poor/HER2(-), resectable breast cancer and (b) the subset of patients with
basal-like breast cancers, as defined by gene expression array.

II. To assess whether there is an interaction between the addition of carboplatin and
bevacizumab to neoadjuvant chemotherapy (NAC) with weekly paclitaxel followed by ddAC as
regards the path pCR rates in (a) patients with HR-poor/HER2(-), resectable breast cancer
and (b) the subset of patients with basal-like breast cancers, as defined by gene expression

III. To assess the toxicity of the control regimen (weekly paclitaxel followed by ddAC) and
any incremental toxicities associated with the addition of carboplatin and/or bevacizumab in
this patient population, including the incidence of febrile neutropenia, grade > 3
thrombocytopenia, grade > 2 neurotoxicity, grade > 3 hypertension, and clinically
significant bleeding or thrombotic (including cardiovascular and cerebrovascular) events.

IV. To determine the recurrence-free survival (RFS) measured from definitive surgery to
first event, and time to first failure (TFF) measured from study entry to first event (see
Sec 16.2).

V. To determine overall survival (OS), defined as time from registration to death from any

VI. To assess the impact of NAC with weekly paclitaxel followed by ddAC, with or without
carboplatin and/or bevacizumab, on axillary lymph node involvement at surgery, particularly
in patients with clinically or histologically positive axillary lymph nodes prior to
initiation of NAC.

VII. To assess the impact of the addition of bevacizumab to NAC on the incidence and
severity of post-op complications, especially excessive bleeding, delayed wound healing, and
thrombotic complications.

VIII. To evaluate residual cancer burden (RCB) as a predictor of RFS, TFF and OS.

IX. To determine the correlation between clinical, radiographic, and pathologic response.

X. Given the prevalence of the triple-negative phenotype in young African-American women,
the study team, the CALGB Committee on Advocacy, Research Communications and Ethics (CARE)
and the CARE Disparities Subcommittee will collaborate to develop a plan intended to enhance
accrual of this patient subgroup.


I. To assess whether the impact of the addition of carboplatin and/or bevacizumab to NAC
with weekly paclitaxel followed by ddAC on achievement of pathologic CRs in patients with
HR-poor/HER2(-), resectable breast cancer is influenced by molecular subtype, as defined by
gene expression array.

II. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for
which biomarker data exist and to evaluate biomarkers in tissue, blood, and serum that may
influence response to and toxicity of weekly paclitaxel, ddAC, carboplatin, and/or

III. To obtain blood samples to test specific hypotheses for which biomarker data exist and
to evaluate biomarkers in blood that may influence response to and toxicity of weekly
paclitaxel, ddAC, carboplatin and/or bevacizumab.

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

V. To examine the practice patterns and use of sentinel lymphadenectomy (pre-chemotherapy or
post-chemotherapy) in patients with T2 or T3 breast cancer.

VI. To examine the proportion of patients who presented with T2 or T3 cancers who undergo
mastectomy despite cytoreduction adequate for breast conservation.

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

OUTLINE: This is a multicenter study. Patients are stratified according to clinical stage of
disease (II vs III). Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients
then receive dose-dense doxorubicin hydrochloride IV over 3-10 minutes and cyclophosphamide
IV over 5-60 minutes (ddAC) once in weeks 13, 15, 17, and 19.

ARM II: Patients receive paclitaxel and ddAC as in arm I. Patients also receive bevacizumab
IV over 30-90 minutes once in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.

ARM III: Patients receive paclitaxel and ddAC as in arm I. Patients also receive carboplatin
IV over 30 minutes once in weeks 1, 4, 7, and 10.

ARM IV: Patients receive paclitaxel and ddAC as in arm I, bevacizumab as in arm II, and
carboplatin as in arm III. Patients in all arms undergo definitive surgery (i.e., modified
radical mastectomy or breast-conserving surgery with appropriate management of the axilla)
between 4-8 weeks after completion of neoadjuvant therapy. Patients undergo core tissue
biopsies at baseline for correlative biomarker studies.

After completion of study treatment, patients are followed periodically for up to 10 years.

Inclusion Criteria:

- Histologically confirmed invasive breast cancer by core needle or incisional biopsy
(excisional biopsy is not allowed)

- Clinical stage II-III disease

- No inflammatory breast cancer

- Resectable disease

- Intent to undergo surgery after completion of neoadjuvant therapy

- Hormone receptor status poor, defined as estrogen receptor-negative and progesterone
receptor-negative tumor OR staining present in ≤ 10% of invasive cancer cells by IHC

- HER2-negative disease, defined as IHC0-1+ OR FISH ratio (HER2 gene copy/chromosome
17) of < 2.0

- Measurable disease, defined as clinically orradiographically measurable target lesion
in the breast that is ≥ 1 cm

- No axillary disease only (i.e., no identifiable tumor in the breast that is ≥ 1
cm onphysical exam or radiographic study)

- Multicentric or bilateral disease allowed provided the target lesion meets the above
eligibility criteria

- Concurrent registration on CALGB-150709 required

- Menopausal status not specified

- Zubrod performance status 0-1

- Granulocytes ≥ 1,000/μL

- Platelets ≥ 100,000/μL

- Total bilirubin ≤ 1.5 times upper limit of normal(ULN)

- ALT ≤ 2.5 times ULN

- Creatinine clearance> 30 mL/min

- Urine protein ≤ 1+ by urinalysis OR urine protein:creatinine ratio < 1 OR 24-hour
urine protein < 1 g

- PT/INR ≤ 1.5 times ULN (INR ≤ 3 times ULN if patient is on stable, therapeutic doses
of warfarin and has no active bleeding or pathologic condition that is associated
with a high risk of bleeding)

- LVEF > lower limit of normal by MUGA scan or echocardiogram

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective, non-hormonal contraception during the entire
period of study treatment

- No significant history of bleeding (e.g., hemoptysis, upper or lower gastrointestinal
bleeding) within the past 6 months

- No serious or non-healing wound, skin ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No baseline neuropathy ≥ grade 2

- No congestive heart failure

- No myocardial infarction, unstable angina pectoris, arterial thrombotic event,
stroke, or transient ischemia attack within the past 12 months

- No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic
BP > 90 mm Hg), uncontrolled or symptomatic arrhythmia, or peripheral vascular
disease ≥ grade 2

- More than 28 days since prior and no concurrent major surgical procedure; the
following are NOT considered to be major surgical procedures:

- Obtaining the required research needle biopsies

- Placement of a radiopaque clip to localize a tumor or tumors for subsequent
surgical resection

- Placement of a port for central venous access

- Fine needle aspiration of a prominent or suspicious axillary lymph node

- Needle biopsy of a clinically or radiographically detected lesion to rule out
metastatic disease

- Pretreatment sentinel lymph node sampling

- No prior chemotherapy, hormonal therapy, or radiotherapy with therapeutic intent for
this cancer

- No other concurrent chemotherapy

- No concurrent hormonal therapy, except steroids for adrenal failure or hormones for
non-disease-related conditions (e.g., insulin for diabetes, dexamethasone as
pre-treatment for paclitaxel, or dexamethasone as an antiemetic)

Type of Study:


Study Design:

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

Outcome Measure:

Pathologic complete response (pCR), defined as the absence of residual invasive carcinoma in the breast

Outcome Description:

Will use two separate chi-square tests, one for each factor, to assess the difference in proportion of pCR in the breast between the control and experimental groups. Will use exact binomial methods to construct 95% confidence intervals around the pCR incidence by factor.

Outcome Time Frame:

At the time of definitive surgical removal

Safety Issue:


Principal Investigator

William Sikov

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • Male Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



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Greenville Memorial HospitalGreenville, South Carolina  29605
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Sanford Cancer Center-Oncology ClinicSioux Falls, South Dakota  57104
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Auburn Regional Medical CenterAuburn, Washington  98002
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Saint Francis HospitalFederal Way, Washington  98003
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Providence - Saint Peter HospitalOlympia, Washington  98506-5166
Good Samaritan Community HospitalPuyallup, Washington  98372
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Northwest CCOPTacoma, Washington  98405
Multicare Health SystemTacoma, Washington  98415
Saint Clare HospitalTacoma, Washington  98499
Saint Joseph Medical CenterTacoma, Washington  98405
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311-6519
Vince Lombardi Cancer Clinic-MarinetteMarinette, Wisconsin  54143
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Women and Infants HospitalProvidence, Rhode Island  02905
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Jupiter Medical CenterJupiter, Florida  33458
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Elkhart ClinicElkhart, Indiana  46515
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Harbin Clinic Medical Oncology and Clinical ResearchRome, Georgia  30165
Michiana Hematology Oncology PC-ElkhartElkhart, Indiana  46514
Michiana Hematology Oncology PC-PlymouthPlymouth, Indiana  46563
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
Michiana Hematology Oncology-PC WestvilleWestville, Indiana  46391
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Michiana Hematology Oncology PC-NilesNiles, Michigan  49120
Central Care Cancer Center-Carrie J Babb Cancer CenterBolivar, Missouri  65613
Skaggs Cancer CenterBranson, Missouri  65616
University of Missouri - Ellis FischelColumbia, Missouri  65203
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
Rex Cancer CenterRaleigh, North Carolina  27607
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
Roper HospitalCharleston, South Carolina  29401
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Medical OncologyGreer, South Carolina  29650
Erlanger Medical CenterChattanooga, Tennessee  37403
Nashville Oncology Associates PCNashville, Tennessee  37203
Sandra L Maxwell Cancer CenterCedar City, Utah  84720
Intermountain Medical CenterMurray, Utah  84157
Utah Valley Regional Medical CenterProvo, Utah  84603
Dixie Medical Center Regional Cancer CenterSaint George, Utah  84770
Utah Cancer Specialists-Salt Lake CitySalt Lake City, Utah  84106
Virginia Oncology Associates-HamptonHampton, Virginia  23666
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Aurora Medical Center in SummitSummit, Wisconsin  53066
Texas Tech University Health Sciences CenterLubbock, Texas  79430
FirstHealth of the Carolinas-Moore Regional HosiptalPinehurst, North Carolina  28374
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
Epic Care-OaklandOakland, California  94612
Salinas Valley MemorialSalinas, California  93901
Saint Vincent's Medical CenterBridgeport, Connecticut  06606
Greenwich HospitalGreenwich, Connecticut  06830
Wilcox Memorial Hospital and Kauai Medical ClinicLihue, Hawaii  96766-1099
Saint Luke's South HospitalOverland Park, Kansas  66213
Kansas City CCOPPrairie Village, Kansas  66208
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
Heartland Hematology and Oncology Associates IncorporatedKansas City, Missouri  64118
Saint John's Clinic-Rolla-Cancer and HematologyRolla, Missouri  65401
Saint Joseph Oncology IncSaint Joseph, Missouri  64507
Comprehensive Cancer Care PCSaint Louis, Missouri  63141
Coney Island HospitalBrooklyn, New York  11235
Forsyth Memorial HospitalWinston-Salem, North Carolina  27103
Saint Francis HospitalGreenville, South Carolina  29601
Hematology Oncology Associates of Fredericksburg IncFredericksburg, Virginia  22401
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
United General HospitalSedro-Woolley, Washington  98284
Gundersen LutheranLa Crosse, Wisconsin  54601
Saint Nicholas HospitalMadison, Wisconsin  53715
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Providence Saint Mary Regional Cancer CenterWalla Walla, Washington  99362
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Norris Cotton Cancer Center-ManchesterManchester, New Hampshire  03104
Aurora West Allis Medical CenterWest Allis, Wisconsin  53227
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California  94704
Michiana Hematology Oncology PC-MishawakaMishawaka, Indiana  46545-1470
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PCEast Syracuse, New York  13057
Summa Akron City HospitalAkron, Ohio  44304
Roy and Patricia Disney Family Cancer CenterBurbank, California  91505
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Aurora Cancer Care-Milwaukee WestWauwatosa, Wisconsin  53226
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
NEA Baptist Memorial HospitalJonesboro, Arkansas  72401
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Toledo Clinic Cancer Centers-Bowling GreenBowling Green, Ohio  43402
Toledo Clinic Cancer Centers-MaumeeMaumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-ToledoToledo, Ohio  43623
Guthrie Clinic-Robert Packer HospitalSayre, Pennsylvania  18840
Self Regional HealthcareGreenwood, South Carolina  29646
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
Sutter Pacific Medical FoundationSanta Rosa, California  95403
Maine Center for Cancer Medicine and Blood Disorders-ScarboroughScarborough, Maine  04074
Fox Valley Surgical Associates LimitedAppleton, Wisconsin  54911
NEA Baptist Clinic-MatthewsJonesboro, Arkansas  72401
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalMilford, Massachusetts  01757
Nash General HospitalRocky Mount, North Carolina  27804
Breastlink Medical Group IncLong Beach, California  90806
Cancer Center of South Florida Foundation Inc-Lake WorthLake Worth, Florida  33461