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A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Canc

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Trial Conditions
  • Breast Cancer
  • Male Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
What is the purpose of this trial?

This randomized phase III trial studies doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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 bevacizumab, 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. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the breast at significant risk of distant
recurrence based on at least one of the following criteria:

- Involvement of at least one sentinel or axillary lymph node on routine
histologic examination; patients with negative sentinel nodes and negative
axillary nodes or involvement only demonstrated by immunohistochemistry are not
eligible unless they meet one of the other eligibility criteria below

- Estrogen receptor (ER) negative tumor >= 1 cm

- ER+ tumor >= 5 cm regardless of recurrence score

- ER+ tumor >= 1 cm but < 5 cm with a recurrence score >= 11; (patients enrolled
in the TAILORx trial are eligible)

- Patients must have completed definitive breast surgery including total mastectomy and
axillary dissection (modified radical mastectomy), total mastectomy and sentinel node
biopsy, breast conservation surgery and axillary dissection or breast conservation
surgery and sentinel node biopsy

- Margins of breast conservation surgery or mastectomy must be histologically free of
invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection
margins positive for lobular carcinoma in situ (LCIS) are eligible

- Time from last surgery for breast cancer (breast conservation surgery, mastectomy,
sentinel node biopsy, axillary dissection or re-excision of breast conservation
surgery margins) to planned treatment start date must be > 28 days and =< 84 days

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

- Absolute neutrophil count >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Total bilirubin =< 1.5 mg/dL

- Aspartate transferase (AST) =< 2 times upper limit of normal(ULN)

- Serum creatinine =< 1.5 mg/dL

- Urine protein:creatinine ratio < 1.0 or 24-hour protein

- Partial thromboplastin time (PTT) =< 1.5 times ULN

- Left ventricle ejection fraction (LVEF) >= institutional limits of normal by
echocardiogram (ECHO) or multigated acquisition scan (MUGA)

- Patients who have undergone breast conservation surgery must receive radiation; prior
to randomization, the investigator must specify the planned radiation technique:

- Whole breast radiation (WBRT) after chemotherapy

- Accelerated partial breast radiation (APBI) after chemotherapy

- Accelerated partial breast radiation (APBI) prior to chemotherapy

- Post-mastectomy radiation therapy (RT) is required for all patients with a primary
tumor of >= 5 cm or involvement of 4 or more lymph nodes; post-mastectomy RT may be
administered at the investigator's discretion for all other mastectomy patients

- Patients with human epidermal growth factor receptor (HER)2 + (3+ by
immunohistochemistry [IHC] or fluorescent in situ hybridisation [FISH] ratio >= 2)
breast cancer are not eligible

- Patients with synchronous bilateral breast cancer (diagnosed within one month) are
eligible if the higher TNM stage tumor meets the eligibility criteria for this trial

- Patients must not have clinical evidence of inflammatory disease or fixed axillary
nodes at diagnosis

- Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for
this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane
for any condition is not allowed

- Patients must not have had any major surgical procedure within 28 days of planned
treatment start date

- Patients may not have had placement of a vascular access device within 24 hours of
planned Day 1 of treatment

- Patients must not have clinically significant cardiovascular or cerebrovascular
disease, including:

Any history of

- Cerebrovascular disease including transient ischemic attack (TIA), stroke or
subarachnoid hemorrhage

- Ischemic bowel within the last 12 months

- Myocardial infarction

- Unstable angina

- New York Heart Association (NYHA) class II or greater congestive heart failure

- Grade II or greater peripheral vascular disease

- Uncontrolled hypertension defined as systolic blood pressure (SBP) > 160 or diastolic
blood pressure (DBP) > 90

- Uncontrolled or clinically significant arrhythmia

- Patients who require full-dose anticoagulation may enroll provided they meet the
following criteria:

- The patient must have an in-range International Normalized Ratio (INR) (usually
between 2 and 3) on a stable dose of warfarin or be on stable dose of low molecular
weight (LMW) heparin

- The patient must not have active bleeding or pathological conditions that carry high
risk of bleeding (e.g. varices)

- Patients must not have a bleeding diathesis, hereditary or acquired bleeding
disorder or coagulopathy

- Patients must not have a non-healing wound or fracture; patients with an
abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 6 months prior to randomization are not eligible

- Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle
Cremophor, Chinese hamster ovary cell products or other recombinant human
antibodies

- Women must not be pregnant or breast-feeding due to the potential harmful
effects of bevacizumab on the developing fetus; all females of childbearing
potential must have a blood or urine test within 7 days prior to randomization
to rule out pregnancy

- Women of childbearing potential and sexually active males must use an accepted
and effective method of contraception

Gender: Both
Steward Physician(s)
  • Kathy Miller
  • Ramona Swaby, MD
  • Donald W. Northfelt, MD, FACP
  • Chau T. Dang, MD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • bevacizumab
Drug
  • doxorubicin hydrochloride
  • cyclophosphamide
  • paclitaxel
Other
  • placebo
Physician Researcher

Investigator Name:

  • Kathy Miller
  • Ramona Swaby, MD
  • Donald W. Northfelt, MD, FACP
  • Chau T. Dang, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00433511
Volunteers:  Not Accepting Healthy Volunteers

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