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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The First Affiliated Hospital of Hainan Medical University | OTHER_GOV |
| Shandong Cancer Hospital and Institute | OTHER |
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Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.
The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome.
Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy | Experimental | Patients who meet the criteria for enrollment initially receive four cycles of TCb (HP) * neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) * neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy | Radiation | Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) * : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year EFS | 5 years event-free survival after neoadjuvant chemoradiotherapy | 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| b-pCR | Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0) | 18 weeks |
| OS | overall survival after completing of neoadjuvant chemoradiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHENGJUN YANG, MD | Contact | 8613512891631 | yangxinpiaoxue001@163.com | |
| QINGSONG PANG, MD | Contact | 8618622221203 | pangqingsong@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| XUCHEN CAO, MD | TianJin Medical University Cancer Institute and Hospitall | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university cancer institute and hospital | Recruiting | Tianjin | China |
Patient baseline information, patient safety information
March 30, 2027
Medical scholars in the world
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| First Affiliated Hospital of Kunming Medical University |
| OTHER |
| Chongqing University Cancer Hospital | OTHER |
| Tangshan People's Hospital | OTHER |
| Taizhou Hospital | OTHER |
Chemotherapy combined with radiotherapy
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Masking Description
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|
| 60 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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