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Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer


- Participants will receive bevacizumab intravenously every 2 weeks. They will also
receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments
will alternate between receiving all three drugs (1st week, third week, fifth week,
etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth
week, etc.) A treatment cycle lasts four weeks.

- During all treatment cycles a physical exam will be performed and the participant will
be asked general health and specific questions about any problems they are
experiencing.

- X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in
order to assess the effect of the study treatment on the participants cancer. These
tests are considered standard of care in patients receiving chemotherapy.

- Once a week blood counts will be performed and at least every 4 weeks, chemistry and
other tests to measure any additional effect of the study drug and disease status will
be checked. These tests are also considered standard of care for patients receiving
chemotherapy.

- At the beginning of the study and at the 4- and 8-week time point, additional blood
will be drawn in order to conduct research blood tests to measure the presence of
cancer cells in the blood.

- A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the
participant in on the study.

- Participants can remain on the research study as long as the study treatment appears to
be working and they are not experiencing unacceptable side effects.


Inclusion Criteria:



- Histologically or cytologically confirmed invasive breast cancer, with metastatic
disease.

- HER2-positive tumor

- Measurable disease defined as at least one lesion that can be accurately measured in
at least one dimension as 20mm or greater with conventional techniques or as 10mm or
greater with spiral CT scan

- 18 years of age or older

- Life expectancy of more than 12 weeks

- ECOG Performance Status of 0 or 1

- Normal organ and marrow function as outlined in the protocol

- Left ventricular ejection fraction 50% or greater as determined by RVG or
echocardiogram within 30 days prior to initiation of protocol therapy

- Patients with stable or previously treated CNS metastases are eligible for study
participation, provided there is no history of clinically significant CNS bleeding

- Men and women of child-bearing potential must agree to use adequate contraception
prior to study entry and for the duration of study participation

COHORT A:

- No prior chemotherapy for treatment of metastatic breast cancer

- May NOT have received prior treatment with trastuzumab for recurrent or metastatic
breast cancer

- No prior vinorelbine for treatment of breast cancer

- No prior bevacizumab for treatment of breast cancer

- May have received prior radiation therapy and/or any number of lines of hormonal
therapy

- Prior trastuzumab therapy in the adjuvant setting is also allowed, providing that
relapse occured at least 12 months following the last dose

- Must have recovered from all reversible toxicities related to prior therapy and may
not have any pre-existing treatment-related toxicities in excess of Grade 1.
Patients must have stopped prior radiation therapy at least 7 days prior to beginning
protocol treatment

COHORT B:

- One prior line of chemotherapy for treatment of metastatic breast cancer or
recurrence of breast cancer within 12 months of completion of adjuvant trastuzumab

- No prior vinorelbine for treatment of breast cancer

- No prior bevacizumab for treatment of breast cancer

- May have received prior radiation therapy and/or any number of lines of hormonal
therapy

- Must have recovered from all reversible toxicities related to prior therapy and may
not have any pre-existing treatment-related toxicities in excess of Grade 1.
Patients must have stopped prior radiation therapy at least 7 days prior to beginning
protocol treatment

Exclusion Criteria:

- Patients who have had chemotherapy within 14 days prior to entering the study, ot
those who have not recovered adequately from adverse events due to agents
administered earlier

- Concurrent radiation therapy

- History of Grade 3 or 4 allergic reactions attributed to compounds of similar
chemical or biologic composition as the agents used in this study

- Prior therapy with bevacizumab or vinorelbine

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a Genentech-sponsored
bevacizumab cancer study

- Inadequately controlled hypertension

- Prior history of hypertensive crisis of hypertensive encephalopathy

- NHYA Grade II or greater congestive heart failure

- History of myocardial infarction of unstable angina within 6 months prior to study
enrollment

- History of stroke or transient ischemic attack within 6 months prior to study
enrollment

- Progressive or untreated CNS metastases

- Significant vascular disease within 6 months prior to study enrollment

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28
days prior to study enrollment or anticipation of need for major surgical procedure
during the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of vascular access
device, within 7 days prior to study enrollment

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

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

- Proteinuria at screening

- Pregnant or lactating

- Current and ongoing treatment with full-dose warfarin or its equivalent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.

Outcome Description:

Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Harold J. Burstein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

07-214

NCT ID:

NCT00670982

Start Date:

May 2008

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • HER2 positive
  • bevacizumab
  • vinorelbine
  • trastuzumab
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Hartford HospitalHartford, Connecticut  06102-5037
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Faulkner HospitalJamaica Plain, Massachusetts  02130
Lowell General HospitalLowell, Massachusetts  01854
New Hampshire Oncology-Hematology PAHooksett, New Hampshire  03106