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Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: October 30, 2006   Last Updated: March 24, 2009   History of Changes
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00394251
  Purpose

The primary objective of this study is to compare the safety of dose-dense Abraxane 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense AC chemotherapy. Bevacizumab will be administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.


Condition Intervention Phase
Breast Cancer
Drug: Cytoxan
Drug: Neulasta
Drug: Bevacizumab
Drug: ABI-007
Drug: Taxol
Drug: Adriamycin
Drug: ABI-007 plus Bevacizumab
Drug: ABI-007 plus Bevacizuman
Drug: ABI-007 plus Bevacizumag
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: An Open-Label, Randomized, Comparative Pilot Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:
  • The primary safety endpoint is the incidence of treatment-emergent toxicities as 3 and 6 months following the completions of chemotherapy. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • The secondary safety endpoints are [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Chemotherapy delivered in terms of : cumulative dose of chemotherapy delivered (mg/m^2), average dose intensity (mg/m^2/week), and the incidence of patients experiencing dose modifications, dose interruptions, and premature discontinuation of study drug. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Change in percent left ventricular fraction (% LVEF). [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Laboratory abnormalities and myelosuppression. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Pegfilgrastim use [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2006
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ABI-007 plus Bevacizumab
Drug: Cytoxan
With Adviamejcin every two weeks X4 cycles.
Drug: Neulasta
On D2 X8 cycles
Drug: Bevacizumab
10mg/kg every two weeks X8 cycles, then 15mg/kg every three weeks X10 doses
Drug: ABI-007
260mg/m2 IV every two weeks X4 cycles
Drug: Taxol
175mg/m2 every to weeks X4 cycles
Drug: Adriamycin
With Cyctoxan every two weeks X4 cycles
Drug: ABI-007 plus Bevacizumab
125mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: ABI-007 plus Bevacizuman
125mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: ABI-007 plus Bevacizumag
125mg1m^2,IV on days 1,8,15 of 28 day cycle
2: Experimental
ABI-007 plus Bevacizumab
Drug: ABI-007 plus Bevacizumab
125mg/m^2.IV on days 1,8,15 of 28 day cycle

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if all of the following criteria are met:

  • Females, age greater than or equal to 18 to less than or equal to 70 years old.
  • ER and PR status have been determined.
  • Operable, histologically confirmed adenocarcinoma of the breast
  • Must meet 1 of the following criteria:
  • T1-3, N1-3, M0, regardless of ER or PR status.
  • T > 2 cm, N0, M0 (T2-3N0M0), regardless of ER or PR status.
  • T > 1 cm, N0, M0, ER or PR positive and grade 3
  • Patients with one sentinel lymph node metastasis 0.2-2 mm in size are not required to undergo completion axillary dissection unless only 1 sentinel lymph node was examined. This completion axillary dissection is optional if 1 out of 2 or more sentinel lymph nodes is positive for a micrometastasis. Therefore if 1 of 1 sentinel lymph node is positive for micrometastasis(0.2-2 mm), then a completion axillary dissection is required.
  • Patients with more than one sentinel node micrometastasis or 1 node with a micrometastasis > 2 mm and/or T3 disease must undergo completion, standard axillary dissection. -Note: the following are not eligible-

T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease [i.e., patients with fixed tumor, peau d'orange skin changes, skin ulcerations, or inflammatory changes

  • Note: Sentinel lymph node micrometastasis < 0.2 mm in considered N0 disease
  • Negative surgical margins on lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on DCIS).
  • ECOG performance status 0-1
  • Normal ECG (as assessed by the investigator).
  • No pre-existing peripheral neuropathy.
  • It has not been longer than 84 days since the date of definitive surgery (eg, mastectomy or in the case of a breast-sparing procedure, axillary dissection).
  • Laboratory values must be as follows:
  • White blood cell count: > or equal to 3,000/mm^3
  • Absolute neutrophil count:> or equal to 1,500/mm^3
  • Platelets:> or equal to 100,000/mm^3
  • Hemoglobin: > or equal to 8g/dL
  • Bilirubin:< or equal to the institution's ULN
  • Creatinine: < or equal to 1.7 mg/dL
  • AST and ALT and alkaline phosphatase may be up to 2.5 x institutional.
  • All staging studies including physical exam, chest x-ray, and bone scan must show no evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan are mandatory; however, all other staging studies are at the treating physician's discretion. Any other staging test (eg, CT scans, MRI studies, ultrasound of abdomen, PET scans) must be negative for metastatic disease. An abdominal CT scan or PET scan is mandatory for patients with liver function tests elevated above the ULN to rule out metastatic disease. If the patient has a staging PET scan then a bone scan is not necessary, but a chest x-ray is required.
  • Patient has a negative serum pregnancy test < or equal to 14 days of the first dose of study drug (patients of childbearing potential).
  • If fertile, patient has agreed to us an acceptable method of birth control to avoid pregnancy [Note: oral contraceptives are not allowed] for the chemotherapy and hormonal therapy and for 6 months thereafter.
  • If obese, a patient must be treated with doses calculated using his/her actual BSA (the physician must be comfortable treating at the full BSA dose regardless of BSA).
  • Patient has signed a Patient Informed Consent Form.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

  • Patients with HER-2 positive breast cancer (IHC 3+ or FISH +) who are eligible for adjuvant Herceptin therapy.
  • Stage IV breast cancer (M1 disease on TNM staging system).
  • Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy
  • Neoadjuvant therapy for this breast cancer.
  • Previous invasive cancers if treated < 5 years prior to entering this study, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; the latter are not required to have occurred more than 5 years prior to study entry.
  • Prior invasive breast cancer if diagnosed < 5 years prior to entering study. Patients must have finished adjuvant hormonal therapy prior registration. Patients with prior DCIS are eligible. Patients with DCIS who were treated with tamoxifen must have finished tamoxifen prior to registration.
  • Serious medical illness, other than that treated by this study, which would limit survival to < 4 years, or psychiatric condition that would prevent informed consent and compliance with study treatment.
  • Uncontrolled or severe cardiovascular disease including recent (< or equal to 12 months)
  • Active uncontrolled bacterial, viral (including clinically defined AIDS), or fungal infection
  • Patients with active or chronic hepatitis with abnormal LFTs or patients who are known to be HIV positive.
  • Uncontrolled disease such as uncontrolled diabetes.
  • Any Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Any known CNS disease.
  • Known hypersensitivity to any component of bevacizumab.
  • No history of cerebrovascular accident or transient ischemic attack at any time
  • Active symptomatic vascular disease, e.g.aortic aneurysm or aortic dissection, an no peripheral vascular disease, e.g. claudication, within six months of study entry.
  • No major surgical procedure, open biopsy, or significant traumatic injury within 28 days and no core biopsy or minor surgical procedure (excluding placement of a vascular access device) within seven days of study entry. No anticipated need for major surgical procedure during the course of study -No history of abdominal fistula, gastronial perforation, or intra- abdominal process within six months of study entry.
  • No serious non-healing wound, ulcer, or bone fracture
  • No proteinuria at screening as demonstrated by urine protein: urine creatinine (UPS) ratio of > or equal to 1.0 or urine dipstick for proteinuria > or equal to 2+ (patients discovered to have > or equal to 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < or equal to 1g or protein in 24 hours to be eligible).
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and /or diastolic blood pressure> 100 mmHg on antihypertensive medications) or NYHA Grade 2 or greater congestive heart failure.
  • History or coagulopathy, bleeding diathesis, therapeutic anti coagulation other than low dose or chronic ASA > or equal to 325 mg per day. Low dode coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH) for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
  • LVEF on cardiac ECHO < 50% (or institutional LLN)and > or equal to 70%
  • Patients receiving concurrent immunotherapy.
  • A history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of breast cancer recurrence or which could shorten a patient's survival
  • Patient has had an organ allograft
  • Patient is pregnant or breastfeeding
  • Patient is unable to comply with requirements of study
  • Patient is receiving any other investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394251

  Show 27 Study Locations
Sponsors and Collaborators
Abraxis BioScience Inc.
  More Information

No publications provided

Responsible Party: Abraxis BioScience ( Kristine Mayberry, Clinical Trials Manager )
Study ID Numbers: CA045
Study First Received: October 30, 2006
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00394251     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Adjuvant therapy
bevacizumab
abraxane
Early Stage Breast Cancer

Study placed in the following topic categories:
Skin Diseases
Immunologic Factors
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Bevacizumab
Angiogenesis Inhibitors
Immunosuppressive Agents
Doxorubicin
Anti-Bacterial Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Breast Diseases
Skin Diseases
Growth Substances
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Doxorubicin
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009