Selective Omission of Axillary Surgery in Triple-negative and HER2-positive Breast Cancer After NACT
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated by NACT and converted to ypN0 indicating the efficacy of systemic treatment in local disease control. According to current guidelines, all initial cN0 patients will undergo sentinel lymph node biopsy (SLNB) after NACT and further axillary dissection (ALND) if tumor residual is discovered after SLNB. Data suggest patients who underwent SLNB have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of SLNB might translate into a considerable reduction of physical and emotional distress. Recent studies revealed the association between breast pCR and ypN0 status after NACT. Initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including SLNB. The investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after NACT will not deteriorate survival. In the planned trial, axillary surgery will be completely eliminated for initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT determined by lumpectomy. The trial is designed as a prospective, single-center, single-arm study with a limited number of patients (N=136). Patients will be recruited in China over a period of 36 months. Our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolna zgoda na uczestnictwo w badaniu
- •Potwierdzony biopsją rak piersi pojedynczy, złośliwy, typu triple-negative lub HER2-dodatni
- •Wiek co najmniej 18 lat
- •Guz na etapie cT1c-T3N0M0 przed chemioterapią
- •Negatywny wynik biopsji węzła chłonnego, jeśli wcześniej podejrzewano zajęcie
- •Potwierdzony odpowiedź guza na chemioterapię przedoperacyjną
- •Planowana operacja oszczędzająca pierś z napromienianiem po zabiegu
✗ Disqualifies
- •Historia poprzedniego nowotworu
- •Zajęcie węzłów chłonnych lub przerzuty odległe
- •Ciąża lub karmienie piersią
- •Zapalny rak piersi
- •Brak odpowiedzi guza na chemioterapię przedoperacyjną
- •Planowana mastektomia po chemioterapii
- •Planowane tylko napromienianie śródoperacyjne lub częściowe napromienianie piersi bez dodatkowego napromienienia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- April 18, 2022
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Peking University Cancer Hospital
Beijing, China
Trial contact
TAO OUYANG, M.D
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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