Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00325234
Recruitment Status : Completed
First Posted : May 12, 2006
Results First Posted : May 20, 2011
Last Update Posted : May 20, 2011
Information provided by:
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Pemetrexed
Drug: Carboplatin
Drug: Gemcitabine
Drug: Vinorelbine

  Participant Flow

  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.
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Reporting Groups
Pemetrexed/Carboplatin Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.

Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.

Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

Total Total of all reporting groups

Baseline Measures
   Pemetrexed/Carboplatin   Gemcitabine/Vinorelbine   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   66   135 
[Units: Years]
Mean (Standard Deviation)
 51.9  (11.38)   52.3  (10.40)   52.1  (10.87) 
[Units: Participants]
Female   69   66   135 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
Caucasian   67   61   128 
African   1   3   4 
Hispanic   0   1   1 
East Asian   1   0   1 
West Asian   0   1   1 
Region of Enrollment 
[Units: Participants]
Spain   18   18   36 
Switzerland   5   4   9 
Israel   9   9   18 
Germany   9   12   21 
Italy   16   14   30 
Turkey   5   3   8 
South Africa   7   6   13 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
ECOG 0   39   39   78 
ECOG 1   28   27   55 
ECOG 2   2   0   2 

The Eastern Cooperative Oncology Group (ECOG) scales and criteria are used by doctors to assess disease progression, assess the patient’s living ability, and determine prognosis. The scale is as follows:

0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in activity but ambulatory and able to perform sedentary work. 2-Ambulatory but unable to work. Up and about > 50% of waking hours. 3-Capable of only limited selfcare, confined to bed or chair > 50% of waking hours. 4-Completely disabled. Cannot self care. Totally confined to bed or chair. 5-Dead

Hormonal Receptor Status [1] 
[Units: Participants]
Estrogen and Progesterone Negative   19   21   40 
Estrogen and/or Progesterone Positive   49   44   93 
Unknown   1   1   2 
[1] Hormone receptor status is a positive or negative measure of estrogen (ER) or progesterone (PR) hormone receptors found in cancer cells. In hormone receptor negative tumors, estrogen and/or progesterone are not present in cancer cells. In hormone receptor positive tumors, estrogen and/or progesterone hormone receptors are present in the cancer cells.
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu) [1] 
[Units: Participants]
Positive   12   13   25 
Negative   53   49   102 
Not Performed   0   1   1 
Unknown   4   3   7 
[1] The Human Epidermal Growth Factor Receptor 2 plays an important role in cell growth and development. HER-2/Neu status is determined by an assay. A positive HER-2/Neu result indicates that HER-2 gene receptors are present; negative HER-2/Neu indicates the absence of HER-2 gene receptors.
Tumor Differentiation Grade [1] 
[Units: Participants]
Grade I   6   3   9 
Grade II   25   27   52 
Grade III   32   30   62 
Unknown   6   6   12 

Classification of tumors into one of four grades based upon how similar in appearance the tumor cells are to normal cells, and by how many tumor cells are dividing. The more tumor cells that are dividing, the greater likelihood of tumor growth and the higher the tumor grade. A lower tumor grade is associated with a better prognosis.

Grade 1 - Well-Differentiated, Low cell division Grade 2 - Moderately Differentiated, Moderate cell division Grade 3 - Poorly Differentiated, High cell division Grade 4 - Undifferentiated, High cell division

Pathological Diagnosis [1] 
[Units: Participants]
Carcinoma, Ductal, Breast   64   54   118 
Carcinoma, Lobular, Breast   4   5   9 
Carcinoma, Inflammatory, Breast   1   3   4 
Carcinoma, Mixed Cell, Breast   0   1   1 
Other   0   3   3 
[1] This measure is the specific diagnosis of breast cancer based upon pathological diagnosis.

  Outcome Measures

1.  Primary:   Tumor Response Rate   [ Time Frame: Baseline up to 30 days of follow-up after 21 cycles of treatment ]

2.  Secondary:   Duration of Response (DOR)   [ Time Frame: Time of response to progressive disease (up to 19 months) ]

3.  Secondary:   Time to Progressive Disease (PD)   [ Time Frame: Baseline to measured PD (up to 25.1 months) ]

4.  Secondary:   Time To Treatment Failure (TTTF)   [ Time Frame: Baseline to end of treatment (up to 21.9 months) ]

5.  Secondary:   Time to Response   [ Time Frame: Baseline to response (up to 7.8 months) ]

6.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up) ]

  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
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  More Information