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TerminatedNCT00517361Updated Apr 15, 2014Results posted

Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer

A Phase 2 interventional study of carboplatin and bevacizumab in Metastatic Breast Cancer, sponsored by University of Chicago. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-15.

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Why this study was terminated
This study has been terminated due to poor accrual
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.

02

Conditions studied

  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have pathologically confirmed ER, PR and HER2/neu negative (FISH ratio of \<2.0 or IHC \<1+) metastatic breast cancer. Locally advanced or recurrent disease is also eligible.
  • Patients must have measurable disease
  • Patients must not have received prior chemotherapy for metastatic breast cancer (not including adjuvant therapy). Patients should be > 4 weeks from their most recent chemotherapy or radiation therapy treatment.
  • Age >18 years
  • ECOG performance status \<1 (Karnofsky >80%).
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,500/uL
  • platelets >100,000/uL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) \<2.5X institutional upper limit of normal
  • creatinine within normal institutional limits OR creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • PT INR \< 1.5 (Unless patient is on anticoagulation)
  • urine protein \<1+
  • Tissue from the primary tumor must be available for correlative studies
  • Women of child-bearing potential must agree to use adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Exclusion Criteria:

  • Patients who have had prior therapy with platinum agents or a VEGF inhibitor are not eligible.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases will be excluded
  • Patients may have had prior radiation therapy, provided the patient has measurable disease and there has been clear progression since the completion of radiation therapy. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to therapy administered more than 4 weeks earlier will be excluded.
  • Patients with significant cardiac dysfunction will be excluded
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study, breastfeeding should be discontinued.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin or the other agents administered during the study.
  • Patients with evidence of bleeding diathesis or coagulopathy.
  • Patients with inadequately controlled hypertension will be excluded
  • Patients who have had a stroke or TIA within 6 months of registration will be excluded.
  • Patients with a history of hypertensive crisis or hypertensive encephalopathy will be excluded.
  • Patients with a history of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months of registration.
  • Patient with history of serious non-healing wound, ulcer or bone fracture.
  • Patients with major surgery, open biopsy, or significant traumatic injury within 28 days of registration or anticipated need for surgery during course of study treatment.
  • Patients with a history core biopsy or other minor surgery, excluding venous access device (VAD) placement, within 7 days of registration.
  • Patients with active second malignancy.
  • Known hypersensitivity to any component of bevacizumab (Avastin®).
  • Peripheral neuropathy > Grade 1.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Carboplatin + Avastin

    Drug: carboplatin · Drug: bevacizumab

Interventions

  • AUC 6 in 250mL saline IV over 30 minutes

  • 15mg/kg in 100mL saline IV over 60 - 90 minutes

    Also known as: Avastin

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Time frame: Up to 5 years

Secondary outcomes

  1. Response Rate

    Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

    Time frame: Up to 5 years

  2. Duration of Response

    Time frame: Up to 5 years

  3. Correlation of Response to BRCA1 Methylation Status

    The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.

    Time frame: Up to 5 years

07

Results

Posted Apr 15, 2014

Participant flow

Participant flow — Overall Study
MilestoneCarboplatin + Avastin
Started11
Completed0
Not completed11
Withdrew: Death6
Withdrew: The study was terminated5

Outcome measures

PrimaryProgression Free Survival

Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:
Up to 5 years

No measurements were reported for this outcome.

SecondaryResponse Rate

Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

Time frame:
Up to 5 years

No measurements were reported for this outcome.

SecondaryDuration of Response
Time frame:
Up to 5 years

No measurements were reported for this outcome.

SecondaryCorrelation of Response to BRCA1 Methylation Status

The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.

Time frame:
Up to 5 years

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Carboplatin + Avastin—1/11 (9.1%)9/11 (81.8%)
Most frequent serious events
Most frequent serious events
EventCarboplatin + Avastin
nauseaGeneral disorders1/11
VomitingGastrointestinal disorders1/11
painGeneral disorders1/11
severe weaknessNervous system disorders1/11
Most frequent other events
Showing 10 of 36
Most frequent other events
EventCarboplatin + Avastin
PlateletsInvestigations6/11
FatigueGeneral disorders5/11
nauseaGastrointestinal disorders4/11
Alanine aminotransferase increasedInvestigations3/11
Aspartate aminotransferase increasedInvestigations3/11
LeukocytesInvestigations3/11
NeutrophilsInvestigations3/11
Hemorrhage nasalRespiratory, thoracic and mediastinal disorders3/11
HypertensionVascular disorders3/11
VomitingGastrointestinal disorders2/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Carboplatin + Avastin
Mean47.7 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Carboplatin + Avastin
Female11
Male0
08

Study locations

2 sites
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Oncology Specialists
    Park Ridge, Illinois 60068, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00517361
Collaborators
Genentech, Inc.
Responsible party
Sponsor
First posted
Aug 16, 2007
Start date
Aug 2007
Primary completion
Apr 2011
Completion
Apr 2012
Results posted
Apr 15, 2014
Last update
Apr 15, 2014

Study contacts

Rita Nanda, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Carboplatin · Bevacizumab

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