Trial Outcomes & Findings for Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics (NCT NCT02297230)
NCT ID: NCT02297230
Last Updated: 2018-10-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
12/2014 (up to 12 years)
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics
Baseline characteristics by cohort
| Measure |
Total
n=44 Participants
Total of all reporting groups
|
Arm 1 Capecitabine and RT
n=11 Participants
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
n=11 Participants
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.
r
|
Arm 3: Paclitaxel and RT
n=11 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=21 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=21 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=21 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12/2014 (up to 12 years)Population: Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12/2014 (up to 12 years)Population: Planned Statistical analysis was not performed for this secondary outcome measure. Study Terminated prematurely; PI left institution;
No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12/2014 (up to 12 years)Population: Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.
No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12/2014 (up to 12 years)Population: No data displayed because Outcome Measure has zero total participants analyzed.
Data were not collected as PI left institution prior to enrollment completion. Planned Statistical analysis was not performed for this secondary outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 Capecitabine and RT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 Paclitaxel/Trastuzumab and RT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Paclitaxel and RT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4: Paclitaxel/Trastuzumab and RT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place