Trial Outcomes & Findings for Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer (NCT NCT00193050)
NCT ID: NCT00193050
Last Updated: 2021-10-26
Results Overview
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
18 Months
Results posted on
2021-10-26
Participant Flow
Participant milestones
| Measure |
Intervention
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Neoadjuvant Treatment
STARTED
|
110
|
|
Neoadjuvant Treatment
COMPLETED
|
101
|
|
Neoadjuvant Treatment
NOT COMPLETED
|
9
|
|
Surgery
STARTED
|
103
|
|
Surgery
COMPLETED
|
103
|
|
Surgery
NOT COMPLETED
|
0
|
|
Adjuvant
STARTED
|
87
|
|
Adjuvant
COMPLETED
|
77
|
|
Adjuvant
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Intervention
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Neoadjuvant Treatment
Lack of Efficacy
|
2
|
|
Neoadjuvant Treatment
Intercurrent Illness
|
3
|
|
Neoadjuvant Treatment
Physician Decision
|
2
|
|
Neoadjuvant Treatment
Adverse Event
|
2
|
|
Adjuvant
Physician Decision
|
5
|
|
Adjuvant
Intercurrent Hospitalization
|
3
|
|
Adjuvant
Lack of Efficacy
|
2
|
Baseline Characteristics
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=110 Participants
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsFor the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Outcome measures
| Measure |
Intervention
n=110 Participants
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Pathologic Complete Response (pCR)
|
18 percentage of participants
Interval 11.0 to 26.0
|
SECONDARY outcome
Timeframe: 69 monthsTime to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: * disease progression date (RECIST or clinical) * death date * treatment discontinuation
Outcome measures
| Measure |
Intervention
n=110 Participants
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Time to Treatment Failure (TTF)
|
13 months
Interval 1.0 to 53.0
|
SECONDARY outcome
Timeframe: 48 monthsNumber of participants that are alive at 48th months
Outcome measures
| Measure |
Intervention
n=110 Participants
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Overall Survival (OS)
|
72 Participants
|
Adverse Events
Intervention
Serious events: 17 serious events
Other events: 71 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Intervention
n=110 participants at risk
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Infections and infestations
Febrile Neutropenia
|
10.0%
11/110 • Number of events 15
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.91%
1/110 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
2/110 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
0.91%
1/110 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.91%
1/110 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.91%
1/110 • Number of events 1
|
|
General disorders
Fever
|
0.91%
1/110 • Number of events 1
|
|
Infections and infestations
Infection - Other
|
0.91%
1/110 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.91%
1/110 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • Number of events 1
|
|
Infections and infestations
Infection - Pneumonia
|
0.91%
1/110 • Number of events 1
|
Other adverse events
| Measure |
Intervention
n=110 participants at risk
In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles
Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.
After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.
After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
40.9%
45/110
|
|
Blood and lymphatic system disorders
Platelets
|
17.3%
19/110
|
|
Blood and lymphatic system disorders
Hemoglobin
|
11.8%
13/110
|
|
Gastrointestinal disorders
Nausea
|
12.7%
14/110
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
10/110
|
|
General disorders
Fatigue
|
9.1%
10/110
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
5/110
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER