Clinical trial · Interventional
Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer. PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
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 |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Soy protein isolate
- description
- Administration Prior to Mastectomy or Lumpectomy. Patients receive oral soy protein isolate twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
- interventionNames
- Dietary Supplement: Soy protein isolate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Administration Prior to Mastectomy or Lumpectomy. Patients receive oral placebo twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Undergoing breast biopsy for any stage breast cancer * No excisional biopsy * At least one core biopsy block must contain carcinoma * Definitive surgery (mastectomy or lumpectomy) planned for 2-4 weeks after registration to this study * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Premenopausal Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No known prior hepatic disease Renal: * No known prior renal disease Other: * Not pregnant or nursing * Fertile patients must use effective non-hormonal contraception * No other prior malignancy except nonmelanoma skin cancer * No known prior thyroid disease * No adherence to vegan diet or other special dietary requirements that would preclude study participation * No allergy to study agent * No obesity (body mass index greater than 32) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent birth control pills or other hormonal therapy * No concurrent thyroid hormone replacement medications Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * More than 30 days since prior antibiotics * More than 4 weeks since prior soy products * No routine consumption of greater than 40 mg of soy/day * No other concurrent nutritional supplements, including modular supplements of other isoflavones
References
Publications (0)
Data not yet available