Could Breast-Conserving surgery be safe for women with multiple tumors?
NCT ID NCT07677956
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study looks at whether breast-conserving surgery (removing only the tumor, not the whole breast) is safe for women diagnosed with multifocal or multicentric breast cancer—meaning they have two or more tumors in one breast. Researchers will follow 100 adult women for at least 3 years after surgery, tracking how often the cancer comes back in the same breast, any complications, and how satisfied patients feel with their appearance and quality of life. All participants receive standard treatments like radiation and medication as needed, and the goal is to see if this less invasive approach works as well as mastectomy for these patients.
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 confirm that breast-conserving surgery is a safe option for women with multiple tumors in one breast, potentially sparing them from mastectomy.
- What could go wrong
- This is an observational study with no comparison group, so results may not prove superiority over mastectomy. The small size (100 participants) limits how broadly findings can be applied.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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.
Who is studied
This single-center prospective cohort enrolls women aged ≥18 years with an ECOG performance status of 0-1 and pathologically confirmed unilateral multifocal/multicentric breast cancer without distant metastasis. Eligible candidates are suitable for breast-conserving surgery with negative margins and postoperative adjuvant radiotherapy. Patients with inflammatory breast cancer, extensive unresectable lesions, severe vital organ dysfunction, pregnancy or lactation, or poor follow-up compliance will be excluded. All participants provide written informed consent and receive standard routine treatment, with long-term follow-up conducted to observe oncological outcomes, surgical complications and patient-reported quality of life.
- Ages
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18 years and older
- 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 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 2. Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS); 3. Radiologically confirmed unilateral multifocal or multicentric breast cancer; 4. No systemic distant metastasis detected on preoperative imaging; 5. Comprehensive clinical evaluation predicts all tumor lesions can be completely resected by breast-conserving surgery (BCS) to obtain negative surgical margins, and patients are suitable for standardized adjuvant whole-breast radiotherapy postoperatively; 6. Adequate function of vital organs (cardiac, hepatic, renal and hematopoietic systems) to tolerate surgery, subsequent adjuvant radiotherapy and chemotherapy; 7. Voluntarily agree to participate in the study after fully understanding the study purpose, procedures, potential risks and benefits, and provide written informed consent. Exclusion Criteria: 1. Inflammatory breast cancer; 2. Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins; 3. Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy; 4. Pregnant or lactating women who are ineligible for postoperative radiotherapy; 5. Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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