Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
Conditions
Brief summary
The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.
Interventions
DRUGpemetrexed
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have been diagnosed with either advanced or metastatic breast cancer. * Chemotherapy has not been given for advanced or metastatic breast cancer. * The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery. * Able to carry out work of a light nature (for example, light housework, office work). * Must be at least 18 years old.
Exclusion criteria
* Have received prior bone marrow or peripheral stem cell transplantation. * Have received prior chemotherapy for metastatic breast cancer. * Are currently pregnant or breast-feeding. * Have an active infection that your doctor decides will affect your safety. * Are unable to take folic acid or vitamin B12.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Tumor Response | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up | Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE). |
| Duration of Tumor Response | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause. |
| Progression-Free Survival Time | every 3 cycles (approximately 6-7 weeks) or until patient has disease progression | Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. |
| Overall Survival Time | every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up | Defined as the time from date of first dose to time of death due to any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed 600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not take any study drug | 1 |
| Overall Study | Ineligible after Registration | 1 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age Continuous | 61.4 years |
| Eastern Cooperative Oncology Group Scale Performance Status 0 - Fully Active | 19 participants |
| Eastern Cooperative Oncology Group Scale Performance Status 1 - Ambulatory, Restricted Strenuous Activity | 18 participants |
| Eastern Cooperative Oncology Group Scale Performance Status 2 - Ambulatory, No Work Activities | 0 participants |
| Eastern Cooperative Oncology Group Scale Performance Status 3 - Partially Confined to Bed, Limited Self Care | 0 participants |
| Eastern Cooperative Oncology Group Scale Performance Status 4 - Completely Disabled | 0 participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / — |
| serious Total, serious adverse events | 14 / — |
Outcome results
Primary
Overall Tumor Response
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.
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Overall Tumor Response | Complete Response | 1 participants |
| Pemetrexed | Overall Tumor Response | Partial Response | 8 participants |
| Pemetrexed | Overall Tumor Response | Stable Disease | 14 participants |
| Pemetrexed | Overall Tumor Response | Progressive Disease | 9 participants |
| Pemetrexed | Overall Tumor Response | Best Response Not Evaluable | 3 participants |
Secondary
Duration of Tumor Response
Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Population: Only applies to patients who had a complete or partial response
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Duration of Tumor Response | 7.3 months |
Secondary
Overall Survival Time
Defined as the time from date of first dose to time of death due to any cause.
Time frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
Population: Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Overall Survival Time | 18.9 months |
Secondary
Progression-Free Survival Time
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Population: Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Progression-Free Survival Time | 4.1 months |
Secondary
Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
Time frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Anaemia - Grade 3 | 5 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Anaemia - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Leukopenia - Grade 3 | 4 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Leukopenia - Grade 4 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Neutropenia - Grade 3 | 8 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Neutropenia - Grade 4 | 5 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Constipation - Grade 3 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Constipation - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Nausea - Grade 3 | 3 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Nausea - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Asthenia - Grade 3 | 3 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Asthenia - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Fatigue - Grade 3 | 5 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Fatigue - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Cellulitis - Grade 3 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Cellulitis - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Dehydration - Grade 3 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Dehydration - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Hyperglycaemia - Grade 3 | 3 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Hyperglycaemia - Grade 4 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Dyspnoea - Grade 3 | 4 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Dyspnoea - Grade 4 | 0 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Pleural effusion - Grade 3 | 2 participants |
| Pemetrexed | Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants) | Pleural effusion - Grade 4 | 0 participants |