Clinical trial · Interventional
S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer
Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II 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 |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- surgery
- description
- surgery followed by observation
- interventionNames
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- surgery followed by RT
- description
- Surgery followed by radiation therapy
- interventionNames
- Radiation: radiation therapy
- Procedure: surgery
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0) * Primary tumor no greater than 5 cm * At least 1 but no more than 3 positive axillary lymph nodes * Nodes cannot be positive solely by cytokeratin staining * No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast * No bilateral breast cancer * No active local regional disease * Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months * Surgical margins negative for invasive and noninvasive ductal carcinoma * No gross extracapsular disease or residual disease in the axilla * Microscopic extracapsular extension allowed * No mastectomy after local failure following lumpectomy * Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 21 and over Sex: * Female Menopausal status: * Pre- or post-menopausal Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * See Disease Characteristics * No more than 6 weeks since prior adjuvant chemotherapy * No other prior chemotherapy * Concurrent adjuvant chemotherapy allowed Endocrine therapy: * See Disease Characteristics * Concurrent adjuvant hormonal therapy allowed Radiotherapy: * No prior chest wall or nodal radiotherapy Surgery: * See Disease Characteristics * Breast reconstruction allowed Other: * Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed
References
Publications (0)
Data not yet available