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A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

Inclusion Criteria:

Participants who met the following criteria were eligible for this study:

1. Woman aged 18 to 70 years, inclusive

2. Had histologically proven breast cancer with the most recent surgery done for breast
cancer up to 60 days prior to study registration

3. Had definitive surgical treatment - either mastectomy, or breast conserving surgery
with axillary lymph node dissection (or sentinel lymph node biopsy) for operable
breast cancer (T1-3, clinical N0-1, and M0)

4. Must have been either "lymph node positive" or "high risk lymph node negative"

1. Were lymph node positive participants who had at least 1 axillary lymph node
involved by breast cancer. (with lymph node metastasis >0.2 mm)

2. Were high risk lymph node negative participants had no lymph node involvement
and at least 1 of the following factors:

- tumor size >2 cm

- estrogen receptor (ER) and progesterone receptor (PR) status negative

- histologic and/or nuclear Grade 2/3

- age <35 years

5. Were participants with the Human Epidermal growth factor Receptor 2 (HER2/neu) status
(positive or negative) known at the time of signing the informed consent

6. Had the estrogen and progesterone receptor status known prior to study registration

7. Had Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

8. Had normal cardiac function, confirmed by left ventricular ejection fraction (LVEF)
or shortening fraction (echocardiography [ECHO] or multiple-gated acquisition [MUGA]
scan respectively)

9. Had the following hematology criteria confirmed within 2 weeks prior to study

- Absolute neutrophil count (ANC) >1,500/microL

- Platelets >100,000/microL

- Hemoglobin ≥ 9 g/dL

10. Met hepatic function evaluation criteria for bilirubin and AST levels within 2 weeks
prior to study registration

11. Had completed staging work-up within 35 days (within 1 year for mammography or breast
magnetic resonance imaging (MRI) prior to study registration

12. May have had MammoSite® brachytherapy radiation when performed immediately following
surgery and prior to receiving chemotherapy. The balloon catheter must have been
removed at least 28 days prior to the start of study treatment

13. May have had bilateral, synchronous breast cancer provided one primary tumor met the
staging criteria

14. Women of child bearing potential must have had a negative pregnancy test within 14
days prior to day 1 cycle 1

15. Had consented to using an effective, non-hormonal method of contraception while
receiving study treatment and for at least six (6) months following the last dose of
bevacizumab, and must have been advised not to breast feed for at least six (6)
months following the last dose of bevacizumab.

16. Signed an informed consent prior to beginning any protocol-specific procedures, and
had documented expected cooperation during the study treatment and follow-up periods

Exclusion Criteria:

Participants with the following criteria were excluded from this study:

1. Had prior systemic anticancer therapy for invasive breast cancer
(immunotherapy,hormonotherapy, chemotherapy)

2. Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy

3. Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall
for any other malignancy

4. Was pregnant or lactating

5. Had pre-existing motor or sensory neurotoxicity of a severity >Grade 2 by National
Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0

6. Had cardiac disease or risk for same as follows:

- Any documented myocardial infarction

- Angina pectoris that required the use of anti-anginal medication

- Any history of documented congestive heart failure

- Grade 3 or Grade 4 cardiac arrhythmia (NCI CTCAE, version 3.0)

- Clinically significant valvular heart disease

- Had cardiomegaly

- Had poorly controlled hypertension, i.e., diastolic greater than 100 mmHg.
(Participants who were well controlled on medication were eligible)

- Were currently receiving medications administered for cardiac arrhythmia, angina
or congestive heart failure (e.g., digitalis, beta-blockers, calcium
channel-blockers), that alter cardiac conduction, unless the medications were
administered for other reasons (e.g., hypertension)

7. Had other serious illness or medical conditions including

- History of significant neurologic or psychiatric disorders including psychotic
disorders, dementia or seizures that prohibited the understanding and giving of
informed consent

- Active uncontrolled infection

- Active peptic ulcer

- Unstable diabetes mellitus

- with symptomatic, intrinsic lung disease resulting in dyspnoea at rest

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Urine protein:creatinine ratio >1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, intra-abdominal
abscess, inflammatory bowel disease or other gastrointestinal condition
increasing the risk of perforation within 6 months of beginning chemotherapy

- Serious, non-healing wound, ulcer, or bone fracture

- Known central nervous system (CNS) disease

- History of stroke or transient ischemic attack (TIA)

- Known hepatic cirrhosis

8. Had past or current history of neoplasm other than breast carcinoma, except for:

- Curatively treated non-melanoma skin cancer

- In situ carcinoma of the cervix

- Other cancer curatively treated and with no evidence of disease for at least 10

- Ductal carcinoma in-situ (DCIS) of the breast

- Lobular carcinoma in-situ (LCIS) of the breast

9. Was currently on therapy with any hormonal agent such as raloxifene, tamoxifen, or
other selective estrogen receptor modulators (SERMs), either for osteoporosis or
prevention of breast cancer

10. Had chronic treatment with corticosteroids unless initiated >6 months prior to study
registration and at low dose (<20 mg methylprednisolone or equivalent)

11. Had concurrent treatment with ovarian hormonal replacement therapy

12. Had concurrent treatment with other experimental drugs

13. Had concurrent treatment with any other anticancer therapy

14. Was male

15. Had known hypersensitivity to Chinese hamster ovary products or other recombinant
human or humanized antibodies and/or hypersensitivity to any of the study drugs or
their ingredients (e.g., polysorbate 80 in docetaxel)

16. Had minor surgical procedures within 7 days prior to day 1 of study treatment; or
major surgical procedures within 28 days prior to day 1 of study treatment or had any
anticipated a surgical procedure during the chemotherapy portion of this study

17. Was directly (or was a relative of the study staff) involved in the conduct of the

18. Had a mental condition or psychiatric disorder rendering her unable to understand the
nature, scope, and possible consequences of the study

19. Was unlikely to comply with protocol

Type of Study:


Study Design:

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

Outcome Measure:

Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)

Outcome Description:

The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Vicki Erickson, MSN

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

August 2010

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms



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