New study aims to find which mastectomy method saves more breast sensation
NCT ID NCT07372339
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will compare two surgical techniques for nipple-sparing mastectomy in 170 women with early breast cancer: the traditional open surgery and a newer endoscopic method using small hidden cuts. The main goal is to see which approach leads to better recovery of breast skin sensation six months after surgery. Researchers will also look at safety, appearance, and quality of life to help guide treatment choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors choose the surgical method that best preserves breast skin sensation after mastectomy, improving quality of life for women with early breast cancer.
- What could go wrong
- This is an early-stage trial with only 170 participants, so results may not apply to all patients. Both surgeries carry risks like infection or poor healing, and the study hasn't started yet.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patients aged 18 to 70 years. 2. Unilateral breast cancer confirmed by preoperative pathology. 3. Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction. 4. Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS). 5. Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC). 6. No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue. 7. No evidence of distant metastasis (M0). 8. Clinically node-negative (cN0) as assessed by preoperative examination. 9. No history of neoadjuvant chemotherapy or radiotherapy prior to surgery. 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 11. Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations. 12. The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction. Exclusion Criteria: 1. Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy. 2. Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle. 3. Pregnancy or lactation at the time of enrollment. 4. Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.). 5. Breast size exceeding a D-cup. 6. Body mass index (BMI) \> 30 kg/m². 7. Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold). 8. Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site. 9. Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia). 10. Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively. 11. Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics). 12. Current heavy smoking (\>20 cigarettes per day). 13. Current alcohol abuse or substance addiction. 14. Concurrent or history of other active malignancies 15. Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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