Clinical trial · Observational
Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unavailable to recruit patients.
Summary
Brief summary (as posted)
Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.
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 |
|---|---|---|---|
| Local Recurrence of Malignant Tumor of Breast | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast surgery | Procedure | — | UNRESOLVED |
| Chemotherapy or endocrine therapy or Trastuzumab therapy | Drug | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Traditional BCS
- description
- Breast-conserving surgery. Modified radical mastectomy.
- interventionNames
- Procedure: Breast surgery
- Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy
- Radiation: Radiation therapy
- label
- Oncoplastic-BCS
- description
- Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location. * Superior pedicle mammoplasty / inverted T * Superior pedicle mammoplasty / V scar * Batwing * Inferior pedicle mammoplasty * Racquet mammoplasty/radial scar * vertical-scar mammoplasty
- interventionNames
- Procedure: Breast surgery
- Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Harvard/NSABP/RTOG breast cosmesis grading scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signed * ECOG\<=2 * Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology. * Operable or operable after neoadjuvant chemotherapy. * Extensive, diffuse micro-calcifications on mammography before surgery * No history of breast surgery or breast radiation therapy before. * Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery. Exclusion Criteria: * Multifocal/multicentric diseases noticed before surgery. * Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery. * Tumor size \> 5 cm revealed by physical examination, Ultrasound or mammography before surgery. * Tumor size/breast size ratio \>0.5 revealed by by physical examination, Ultrasound or mammography before surgery. * Have other malignant tumors. * Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients. * Participated in other clinical trials. * Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients. * Patients with any organ failure. * Pregnancy women * Patients who desire to have mastectomy before surgery.
References
Publications (0)
Data not yet available