Clinical trial · Interventional
LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer
NCT00006007CI-TRIAL-00025068completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine + pemetrexed
- description
- Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8. Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response receive 2 additional courses. Patients are followed every 3 months for 5 years.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pemetrexed disodium
Primary outcomes (1)
- measure
- time to progression
- timeFrame
- Up to 5 years
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer with clinical evidence of metastatic disease * Bidimensionally measurable disease * If bisphosphonates used, must have measurable disease site other than bone * No bone only disease * Must have received a prior anthracycline and taxane in the adjuvant and/or metastatic setting * No clinically significant pericardial effusions, pleural effusions, or ascites unless they can be drained * No active CNS metastases * Treated CNS metastasis that has ben stable for at least 8 weeks allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN (5 times ULN if liver metastases) * Albumin at least 3.0 g/dL Renal: * Creatinine clearance at least 45 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take folic acid and cyanocobalamin (vitamin B12) supplements * Body surface area less than 3 m\^2 * No uncontrolled infection * No chronic debilitating disease * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * At least 4 weeks since prior genetic therapy * No concurrent immunomodulating agents Chemotherapy: * See Disease Characteristics * No more than 3 prior chemotherapy regimens including adjuvant therapy * No more than 1 prior chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline * At least 4 weeks since prior chemotherapy * No prior gemcitabine and/or pemetrexed disodium * No other concurrent cytostatic or cytotoxic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to greater than 25% of bone marrow * No prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No aspirin or nonsteroidal antiinflammatory agents 2 days before, the day of, and for 2 days after pemetrexed disodium administration (5 days before for long acting agents such as naproxen, piroxicam, diflunisal, or nabumetone)
References
Publications (2)
- RESULTMa CX, Steen P, Rowland KM, Niedringhaus RD, Fitch TR, Kugler JW, Hillman DW, Perez EA, Ingle JN, Adjei AA. A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study. Ann Oncol. 2006 Feb;17(2):226-31. doi: 10.1093/annonc/mdj054. Epub 2005 Nov 22. PMID 16303865
- RESULTMa CX, Steen P, Rowland KM, et al.: A phase II study of a combination of pemetrexed (Pem) and gemcitabine (Gem) in patients with metastatic breast cancer (MBC): an NCCTG study. [Abstract] J Clin Oncol 22 (Suppl 14): A-639, 36s, 2004.