Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00930930
First received: July 1, 2009
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: October 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: cisplatin
Drug: everolimus
Drug: paclitaxel
Other: placebo
Procedure: Venous blood draw

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This Vanderbilt-Ingram Cancer Center, multi-site intervention study included 7 additional cancer centers. It opened to enrollment in June 2009 and ran through May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred forty-seven patients enrolled in this study. Two patients were not eligible to participate.

Reporting Groups
  Description
Arm I

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Arm II

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment


Participant Flow:   Overall Study
    Arm I     Arm II  
STARTED     96     49  
COMPLETED     75     40  
NOT COMPLETED     21     9  
Death                 1                 0  
Physician Decision                 1                 0  
Adverse Event                 13                 3  
Withdrawal by Subject                 3                 1  
Disease progression                 2                 3  
excessive lapse btw txs, not eligible                 0                 1  
patients not compliant                 1                 1  



  Baseline Characteristics
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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
Arm I

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Arm II

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
  96     49     145  
Age  
[units: years]
Median (Inter-Quartile Range)
  52   (42.8 to 57.2)     52   (43 to 58)     52   (43 to 58)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     87     46     133  
>=65 years     9     3     12  
Gender  
[units: participants]
     
Female     96     49     145  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     96     49     145  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Pathological Complete Response   [ Time Frame: at time of surgery, week 15-18 ]

2.  Secondary:   Number of Patients That Underwent Breast Conservation Surgery   [ Time Frame: at the time of surgery, week 15-18 ]

3.  Secondary:   Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery   [ Time Frame: After treatment, week 12-15 ]

4.  Secondary:   Number of Patients With Each Worst-grade Toxicity Response   [ Time Frame: week 12 ]

5.  Other Pre-specified:   Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes   [ Time Frame: Before treatment, on day 3-5 of week 1, and at week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Ability of p63 and p73 Gene Signatures to Predict Patient Response   [ Time Frame: Before treatment, on day 3-5 of week 1, and at week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The number of participants in each arm will not necessarily coincide with the number of participants affected in the respective arm. Some participants my have more than one event and/or some participants may not have an event at all.


  More Information
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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: Dr. Ingrid Mayer
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-2033
e-mail: ingrid.mayer@vanderbilt.edu


No publications provided


Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00930930     History of Changes
Other Study ID Numbers: VICC BRE 0904, P30CA068485, VU-VICC-BRE-0904, IRB# 090291
Study First Received: July 1, 2009
Results First Received: October 30, 2014
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration