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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

Phase 2
18 Years
70 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

-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

- Active uncontrolled bacterial, viral (including clinically defined AIDS), or fungal

- 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

Type of Study:


Study Design:

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

Outcome Measure:

The primary safety endpoint is the incidence of treatment-emergent toxicities as 3 and 6 months following the completions of chemotherapy.

Outcome Time Frame:

End of Study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • Adjuvant therapy
  • bevacizumab
  • abraxane
  • Early Stage Breast Cancer
  • Breast Neoplasms



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