Clinical trial · Interventional
Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
- 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. Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer. PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alternative product therapy | Procedure | — | UNRESOLVED |
| antineoplaston A10 | Drug | — | UNRESOLVED |
| biologically based therapies | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| cancer prevention intervention | Procedure | — | UNRESOLVED |
| chemotherapy | Procedure | — | UNRESOLVED |
| complementary and alternative therapy | Procedure | — | UNRESOLVED |
| differentiation therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced breast cancer that is refractory or unlikely to respond to hormonal therapy AND failed at least 1 prior chemotherapy regimen * Symptomatic lymphangitic pulmonary dissemination allowed * Extensive visceral metastasis allowed * Patients who are refractory or who have failed to respond after at least 8 weeks of methotrexate or a methotrexate-containing regimen are not eligible * Measurable disease * No bone metastases * Hormone receptor status: * Estrogen receptor negative PATIENT CHARACTERISTICS: Age: * Postmenopausal Sex: * Female Menopausal status: * Postmenopausal Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT no greater than 2 times normal * Blood ammonia normal * No hepatic failure Renal: * BUN less than 60 mg/dL * Creatinine no greater than 2.5 mg/dL * Creatinine clearance greater than 60 mL/min * No chronic renal failure Cardiovascular: * No severe heart disease Pulmonary: * No severe lung disease Other: * No serious active infections or fever * No other concurrent serious disease * No prior or concurrent secondary malignancies within the past 2 years * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent biologic therapy for metastatic breast cancer Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior cytotoxic chemotherapy and recovered * No other concurrent chemotherapy for metastatic breast cancer Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy and recovered * No concurrent hormonal therapy for metastatic breast cancer Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy for metastatic breast cancer Surgery: * Not specified Other: * At least 4 weeks since prior participation in experimental clinical trials * No prior antineoplaston A10 therapy * No other concurrent treatment for metastatic breast cancer * No concurrent salicylates, nonsteroidal anti-inflammatory drugs, phenylbutazone, phenytoin, and sulfonamides
References
Publications (0)
Data not yet available