ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 579 for:    Advanced | cancer | bevacizumab

A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00320541
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 27, 2010
Last Update Posted : July 22, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: gemcitabine
Drug: paclitaxel
Drug: bevacizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
219 patients were screened; 28 patients were screen failures and were not assigned treatment.

Reporting Groups
  Description
Paclitaxel Plus Bevacizumab (PB) paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G) paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

Participant Flow:   Overall Study
    Paclitaxel Plus Bevacizumab (PB)   Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
STARTED   94   93 
COMPLETED   44   36 
NOT COMPLETED   50   57 
Adverse Event                21                19 
Protocol Violation                0                1 
Withdrawal by Subject                12                16 
Physician Decision                9                13 
Other                3                4 
Sponsor Decision                2                1 
Death due to Study Disease                1                3 
Death due to Adverse Event(s)                1                0 
Protocol Entry Criterion Not Met                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paclitaxel Plus Bevacizumab (PB) paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G) paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Total Total of all reporting groups

Baseline Measures
   Paclitaxel Plus Bevacizumab (PB)   Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   93   187 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (10.68)   56.8  (9.56)   57.2  (10.12) 
Gender 
[Units: Participants]
     
Female   94   93   187 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   80   77   157 
African   5   11   16 
Hispanic   7   4   11 
East Asian   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   94   93   187 
Basis for Pathological Diagnosis [1] 
[Units: Participants]
     
Histopathological   84   84   168 
Cytological   10   8   18 
Missing   0   1   1 
[1] Methodology used for obtaining pathological diagnosis
Breakdown According to Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
Fully Active- 0   57   60   117 
Ambulatory, Restricted Strenuous Activity- 1   37   31   68 
Missing   0   2   2 
[1] ECOG Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). In this study, ECOG performance status was assessed within 14 days of Visit 1. Patients were required to have a baseline ECOG Performance Status of 0 or 1 for study participation.
Breakdown by Estrogen Receptor (ER) Status [1] 
[Units: Participants]
     
Positive   60   67   127 
Negative   33   25   58 
Unknown   1   1   2 
[1] Breakdown of participants by ER status
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status [1] 
[Units: Participants]
     
Not done   3   4   7 
Positive   4   2   6 
Negative   87   86   173 
Missing   0   1   1 
[1] Breakdown of participants by HER-2 NEU status
Breakdown by Progesterone Receptor (PR) Status [1] 
[Units: Participants]
     
Not done   1   0   1 
Positive   42   57   99 
Negative   50   35   85 
Unknown   1   1   2 
[1] Breakdown of participants by PR status
Breakdown of Disease-free Interval [1] 
[Units: Participants]
     
Less than or equal to 24 months   5   10   15 
Greater than 24 months   6   2   8 
Not applicable   83   81   164 
[1] Breakdown by treatment arm of disease-free interval which was defined as the duration between prior adjuvant chemotherapy stop date and disease recurrence date for applicable participants who received adjuvant chemotherapy.
Diagnosis by pathology [1] 
[Units: Participants]
     
Ductal breast carcinoma   76   79   155 
Lobal breast carcinoma   9   6   15 
Tubal breast carcinoma   0   0   0 
Medullary breast carcinoma   0   0   0 
Adenocystic breast carcinoma   0   0   0 
Papillar breast carcinoma   0   0   0 
Breast carcinoma   6   3   9 
Other   3   5   8 
[1] Pathology of breast cancer diagnosis
Menopausal Status [1] 
[Units: Participants]
     
Not done   1   1   2 
Pre-menopausal   18   18   36 
Peri-menopausal   2   3   5 
Post-menopausal   73   70   143 
Unknown   0   1   1 
[1] Breakdown of menopausal status
Presence of Visceral Metastases [1] 
[Units: Participants]
     
Yes   68   66   134 
No   25   24   49 
Missing   1   3   4 
[1] Presence of visceral metastases at baseline visit
Prior Biological Treatment for This Cancer [1] 
[Units: Participants]
 0   2   2 
[1] Number of participants, by treatment arm, who had received prior biological treatment for this cancer. NOTE: The total number of participants who received prior biological treatment does not equal the total number of participants in the trial because not all participants received prior biological treatment.
Prior Cancer Surgery [1] 
[Units: Participants]
 79   82   161 
[1] Number of participants, by treatment arm, who underwent prior surgery. NOTE: The total number of participants who underwent prior surgery does not equal the total number of participants in the trial because not all participants underwent prior surgery.
Prior Chemotherapy for This Cancer [1] 
[Units: Participants]
 55   57   112 
[1] Number of participants, by treatment arm, who received prior chemotherapy for this cancer. NOTE: The total number of participants who received prior chemotherapy does not equal the total number of participants in the trial because not all participants received prior chemotherapy.
Prior Exposure to Taxanes [1] 
[Units: Participants]
     
Yes   33   32   65 
No   61   61   122 
[1] Number of participants previously treated with taxane chemotherapy including: Taxol (paclitaxel), Topotecan (docetaxel), or Abraxane (albumin-bound paclitaxel).
Prior Hormonal Treatment for This Cancer [1] 
[Units: Participants]
 51   53   104 
[1] Number of participants, by treatment arm, who received prior hormonal treatment for this cancer. NOTE: The total number of participants who received prior hormonal treatment does not equal the total number of participants in the trial because not all participants received prior hormonal treatment.
Prior Immunological Treatment for This Cancer [1] 
[Units: Participants]
 2   0   2 
[1] Number of participants, by treatment arm, who received prior immunological treatment for this cancer. NOTE: The total number of participants who received prior immunnological treatment does not equal the total number of participants in the trial because not all participants received prior immunological treatment.
Prior Radiotherapy [1] 
[Units: Participants]
 50   55   105 
[1] Number of participants, by treatment arm, who received prior radiotherapy. NOTE: The total number of participants who received prior radiotherapy does not equal the total number of participants in the trial because not all participants received prior radiotherapy.
Body Surface Area (BSA) at Day 1 of Visit 1 
[Units: Square meters (m2)]
Mean (Standard Deviation)
 1.8  (0.18)   1.8  (0.21)   1.8  (0.20) 


  Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months) ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated) ]

3.  Secondary:   Overall Survival   [ Time Frame: baseline to death from any cause (up to 35 months) ]

4.  Secondary:   Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

5.  Secondary:   Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

6.  Secondary:   Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

7.  Secondary:   Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

8.  Secondary:   Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

9.  Secondary:   Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]

10.  Secondary:   Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy   [ Time Frame: Baseline through 30 days post therapy follow-up (up to 35 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Of 191 randomized patients, 4 patients were disqualified from inclusion in any efficacy or safety analyses due to significant Good Clinical Practice (GCP) violations; data is reported for the remaining 187 randomized patients.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00320541     History of Changes
Other Study ID Numbers: 10663
B9E-US-S377 ( Other Identifier: Eli Lilly and Company )
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: April 26, 2010
Results First Posted: July 27, 2010
Last Update Posted: July 22, 2013