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Tests treatment safety and results for Breast Cancer
Official title Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06938360
What this study is testing
- What it's testing
- This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
You likely can't join if
- Tumor-related characteristics
- Metastatic or bilateral breast cancer
- Inflammatory breast cancer
- Multicentric lesions
- Comorbidities/treatment history
- History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy...
See the full eligibility criteria
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
- Paget's disease;
- Neoadjuvant chemotherapy permitted for eligible patients;
- Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
- Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
- Enrolled patients assigned by chance 1:1 to breast-conserving surgery or total mastectomy group;
- Participants voluntarily signed informed consent forms and completed ethics review procedures.
- Tumor-related characteristics
- Metastatic or bilateral breast cancer
- Inflammatory breast cancer
- Multicentric lesions
- Comorbidities/treatment history
- History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
- Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
- Active infections/immune disorders: HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection
- Allogeneic bone marrow/solid organ transplantation history or planned
- Cardiovascular diseases:
- Heart failure or LVEF\<50%
- Uncontrolled arrhythmias (resting heart rate\>100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block)
- Angina requiring antianginal drugs
- Clinically significant valvulopathy
- Transmural myocardial infarction on ECG
- Uncontrolled hypertension (SBP\>180 mmHg and/or DBP\>100 mmHg)
- Reproductive status Pregnancy/lactation, or reproductive-aged women with:
- Positive baseline pregnancy test
- Refusal of effective contraception
- Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
- Other investigator-determined exclusionary conditions
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.