Trial Search Results

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Collaborator: North Central Cancer Treatment Group

Intervention(s):

  • Biological: Bevacizumab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Paclitaxel
  • Other: Placebo
  • Other: Quality-of-Life Assessment

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have histologically confirmed adenocarcinoma of the breast at
   significant risk of distant recurrence based on at least one of the following
   criteria:

      - For axillary lymph node positive disease:

         - 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

         - NOTE: consider intramammary nodes as equivalent to axillary nodes for the
         purposes of eligibility and stratification

      - For axillary lymph node negative disease:

         - 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)

         - NOTE: axillary dissection is strongly encouraged in patients with lymph node
         involvement identified on sentinel node biopsy

   - 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

      - NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and
      excisional 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 aminotransferase (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

      - NOTE: if APBI was completed prior to study entry, day 1 of protocol therapy must
      be at least 4 weeks after the completion of APBI

   - 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 hybridization [FISH] ratio >= 2)
   breast cancer are not eligible

   - Patients with synchronous bilateral breast cancer (diagnosed within one month) are
   eligible if the higher tumor, node, metastasis (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

      - NOTE: prior use of tamoxifen for chemoprevention is allowed but must be
      discontinued at study entry; similarly, prior raloxifene use is allowed but must
      be discontinued at study entry

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

      - NOTE: non-operative biopsy or placement of a vascular access device is not
      considered a major surgery

   - 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

         - NOTE: blood pressure must be obtained within =< 8 weeks prior to
         randomization

         - NOTE: patients with controlled atrial fibrillation are eligible

   - 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)

      - NOTE: prophylactic use of anticoagulants to maintain patency of a vascular access
      device is permitted

   - 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; 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting