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Trial record 12 of 4384 for:    "breast cancer" | ( Map: United States )

Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics

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ClinicalTrials.gov Identifier: NCT02297230
Recruitment Status : Terminated (PI Left Institution prior to reaching accrual goal and analyzing data.)
First Posted : November 21, 2014
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Radiation: Radiation Therapy (RT)
Drug: Capecitabine
Drug: Trastuzumab
Drug: Paclitaxel

  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
No text entered.

Reporting Groups
  Description
Arm 1 Capecitabine and RT

Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).

radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.

Capecitabine: Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks

Arm 2 Paclitaxel/Trastuzumab and RT

Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.

radiation therapy: Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.

Trastuzumab: Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the

Arm 3: Paclitaxel and RT Paclitaxel: Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with
Arm 4: Paclitaxel/Trastuzumab and RT Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.

Participant Flow:   Overall Study
    Arm 1 Capecitabine and RT   Arm 2 Paclitaxel/Trastuzumab and RT   Arm 3: Paclitaxel and RT   Arm 4: Paclitaxel/Trastuzumab and RT
STARTED   11   11   11   11 
COMPLETED   11   11   11   11 
NOT COMPLETED   0   0   0   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
Arm 1 Capecitabine and RT Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
Arm 2 Paclitaxel/Trastuzumab and RT

Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.

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Arm 3: Paclitaxel and RT Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.
Arm 4: Paclitaxel/Trastuzumab and RT Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
Total Total of all reporting groups

Baseline Measures
   Arm 1 Capecitabine and RT   Arm 2 Paclitaxel/Trastuzumab and RT   Arm 3: Paclitaxel and RT   Arm 4: Paclitaxel/Trastuzumab and RT   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   11   11   44 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  90.9%      10  90.9%      10  90.9%      10  90.9%      40  90.9% 
>=65 years      1   9.1%      1   9.1%      1   9.1%      1   9.1%      4   9.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      11 100.0%      11 100.0%      11 100.0%      11 100.0%      44 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   11   11   11   11   44 


  Outcome Measures

1.  Primary:   Feasibility & Efficacy of Chemo-radiation While Targeting Treatment, Based on: Original Tumor Characteristics; to be Followed by [Need for] Conventional Post-operative Chemotherapy   [ Time Frame: 12/2014 (up to 12 years) ]

2.  Secondary:   To Assess the Pathological Response Rate and Compare it to That Achieved in Our Previous Phase I-II Trials of Concurrent Chemo-radiation.   [ Time Frame: 12/2014 (up to 12 years) ]

3.  Secondary:   To Store Core Biopsies of the Original Tumor Before and After Treatment (From the Surgical Specimen) for Future Molecular Biology Studies in LABC.   [ Time Frame: 12/2014 (up to 12 years) ]

4.  Secondary:   To Acquire Descriptive Information on Patient Adherence to Therapy and on Quality of Life During Treatment.   [ Time Frame: 12/2014 (up to 12 years) ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Sylvia Formenti
Organization: New York University School of Medicine
phone: 646.962.4073
e-mail: lao2003@med.cornell.edu



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02297230     History of Changes
Other Study ID Numbers: 10289
First Submitted: October 27, 2014
First Posted: November 21, 2014
Results First Submitted: August 29, 2017
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018