Trial Outcomes & Findings for Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer (NCT NCT00316199)

Last Updated: 2009-06-17

Results Overview

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Results posted on

2009-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine + Paclitaxel Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Overall Study STARTED	60
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine + Paclitaxel Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Overall Study Adverse Event	2
Overall Study Death	8
Overall Study Lost to Follow-up	2

Baseline Characteristics

Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine + Paclitaxel n=60 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Age Continuous	46.9 years STANDARD_DEVIATION 8.96 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment China	60 participants n=5 Participants
Disease Stage at Study Entry Stage IIIB	6 participants n=5 Participants
Disease Stage at Study Entry Stage IV	54 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 0 - Fully Active	30 participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status 1 - Ambulatory, Restricted Strenuous Activity	30 participants n=5 Participants
Menopausal Status Pre-Menopausal	29 participants n=5 Participants
Menopausal Status Peri-Menopausal	7 participants n=5 Participants
Menopausal Status Post Menopausal	22 participants n=5 Participants
Menopausal Status Missing	2 participants n=5 Participants
Pathological Diagnosis Undifferentiated Breast Carcinoma	1 participants n=5 Participants
Pathological Diagnosis Infiltrating Lobular Carcinoma	0 participants n=5 Participants
Pathological Diagnosis Infiltrating Ductal Breast Carcinoma	55 participants n=5 Participants
Pathological Diagnosis Adenocarcinoma	3 participants n=5 Participants
Pathological Diagnosis Comedocarcinoma	0 participants n=5 Participants
Pathological Diagnosis Missing	1 participants n=5 Participants
Race/Ethnicity East Asian (Chinese)	60 participants n=5 Participants
Height	160.3 centimeters STANDARD_DEVIATION 4.35 • n=5 Participants
Weight	62.68 kilograms STANDARD_DEVIATION 9.518 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paclitaxel n=58 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Best Overall Tumor Response Complete Response (CR)	2 participants
Best Overall Tumor Response Partial Response (PR)	27 participants
Best Overall Tumor Response Stable Disease (SD)	20 participants
Best Overall Tumor Response Progressive Disease (PD)	7 participants
Best Overall Tumor Response Early Death from Malignant Disease	0 participants
Best Overall Tumor Response Death from Toxicity	0 participants
Best Overall Tumor Response Early Death from Other Causes	0 participants
Best Overall Tumor Response Unknown	2 participants

SECONDARY outcome

Timeframe: baseline to stopping treatment

Population: All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).

Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paclitaxel n=60 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Time to Treatment Failure	4.5 months Interval 4.1 to 5.3

SECONDARY outcome

Timeframe: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: All enrolled participants. Forty-two participants were censored.

Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paclitaxel n=60 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Progression-Free Survival	7.6 months Interval 5.8 to 8.8

SECONDARY outcome

Timeframe: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)

Population: Enrolled participants who were considered responders (had either a complete response or partial response).

Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paclitaxel n=29 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Duration of Response	5.6 months Interval 4.4 to 7.6

SECONDARY outcome

Timeframe: baseline to date of death from any cause

Population: All enrolled participants. Fifty-two participants were censored.

Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.

Outcome measures

Outcome measures
Measure	Gemcitabine + Paclitaxel n=60 Participants Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Overall Survival Probability 6-Month Overall Survival Probability	97 percent
Overall Survival Probability 12-Month Overall Survival Probability	87 percent

Adverse Events

Gemcitabine + Paclitaxel

Serious events: 1 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine + Paclitaxel Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Injury, poisoning and procedural complications Femur fracture	1.7% 1/60 • Number of events 1

Other adverse events

Other adverse events
Measure	Gemcitabine + Paclitaxel Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression. Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression
Blood and lymphatic system disorders Leukopenia	70.0% 42/60 • Number of events 116
Blood and lymphatic system disorders Neutropenia	76.7% 46/60 • Number of events 115
Blood and lymphatic system disorders Thrombocytopenia	5.0% 3/60 • Number of events 3
Gastrointestinal disorders Abdominal pain	8.3% 5/60 • Number of events 9
Gastrointestinal disorders Constipation	8.3% 5/60 • Number of events 9
Gastrointestinal disorders Diarrhoea	16.7% 10/60 • Number of events 14
Gastrointestinal disorders Nausea	21.7% 13/60 • Number of events 29
Gastrointestinal disorders Vomiting	21.7% 13/60 • Number of events 38
General disorders Fatigue	31.7% 19/60 • Number of events 78
General disorders Pyrexia	16.7% 10/60 • Number of events 13
Investigations Alanine aminotransferase increased	26.7% 16/60 • Number of events 21
Investigations Aspartate aminotransferase increased	18.3% 11/60 • Number of events 15
Investigations Haemoglobin decreased	6.7% 4/60 • Number of events 5
Investigations Neutrophil count decreased	8.3% 5/60 • Number of events 16
Investigations Platelet count decreased	8.3% 5/60 • Number of events 5
Investigations White blood cell count decreased	10.0% 6/60 • Number of events 14
Metabolism and nutrition disorders Anorexia	15.0% 9/60 • Number of events 18
Metabolism and nutrition disorders Hyperglycaemia	6.7% 4/60 • Number of events 4
Metabolism and nutrition disorders Hypertriglyceridaemia	5.0% 3/60 • Number of events 3
Musculoskeletal and connective tissue disorders Arthralgia	35.0% 21/60 • Number of events 64
Musculoskeletal and connective tissue disorders Myalgia	58.3% 35/60 • Number of events 82
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	8.3% 5/60 • Number of events 17
Nervous system disorders Headache	5.0% 3/60 • Number of events 4
Nervous system disorders Neuropathy	16.7% 10/60 • Number of events 11
Nervous system disorders Peripheral sensory neuropathy	46.7% 28/60 • Number of events 74
Respiratory, thoracic and mediastinal disorders Cough	6.7% 4/60 • Number of events 8
Skin and subcutaneous tissue disorders Alopecia	83.3% 50/60 • Number of events 50
Skin and subcutaneous tissue disorders Rash	16.7% 10/60 • Number of events 13
Vascular disorders Flushing	5.0% 3/60 • Number of events 7

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60