Clinical trial · Interventional
Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
NCT01100489CI-TRIAL-00005893withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Estrogen Receptor-negative Breast Cancer | — | UNRESOLVED | — |
| Estrogen Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Invasive Ductal Breast Carcinoma | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
| Invasive Lobular Breast Carcinoma | Invasive Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: external beam radiation therapy
- Other: questionnaire administration
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
- measure
- Ipsilateral breast tumor recurrence rates
- timeFrame
- 5 years after completion of radiation
- description
- Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
- measure
- To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm) * All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies * A maximum of two radiographically detected malignant lesions * Clinical Stage I-II breast carcinoma, with lesion size =\< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =\< 1 cm * Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS * Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision * A posterior margin =\< 2 mm from DCIS is permissible provided fascia was taken * Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification * Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy * Signed study-specific informed consent prior to study entry Exclusion * Extensive intraductal component by the Harvard definition (i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue) * Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative * Patients receiving neoadjuvant chemotherapy * Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines * Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment \>= 50% * Diffuse calcifications throughout the breast * Patients with skin involvement or inflammatory breast cancer * Patients with Paget's disease of the nipple * Patients nonepithelial breast malignancies such as lymphoma or sarcoma * Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis * Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent * Other malignancy, except non-melanomatous skin cancer, \< 5 years prior to participation in this study * Patients who are pregnant or lactating, due to potential fetal exposure to radiation and unknown effects of radiation on lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.