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A multicenter real world study of RecurIndex predicts the necessity of post-operative radiotherapy in pT1-2N1M0 breast cancer

A multicenter real world study of RecurIndex predicts the necessity of post-operative radiotherapy in pT1-2N1M0 breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042491
Enrollment
Unknown
Registered
2021-01-22
Start date
2021-01-31
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Sponsors

Liangning Cancer Hospital &Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Female patients aged 18-70 years. 2) ECoG patients with general state <= 2. 3) Histologically confirmed invasive breast cancer. 4) The primary tumor was treated with modified radical mastectomy, and tumor stage: T1-2,N1. 5) Patients accepted at least 4 courses of adjuvant chemotherapy with anthracycline or taxane. 6) Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy. 7) There must be adequate systemic examination (such as chest X-ray, B-ultrasound, CT, etc.) within 2 months before randomization of radiotherapy to confirm that there is no distant metastasis. 8) The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing. 9) No previous history of malignant tumors, except for basal cell carcinoma of the skin. 10) Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment. 2) Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy. 3) Patients who underwent total mastectomy and only sentinel lymph node biopsy. 4) Have a history of contralateral breast cancer. 5) History of chest radiotherapy. 6) Combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness. 7) Pregnant or lactating women.

Design outcomes

Secondary

MeasureTime frame
recurrence rate;Distant free survival;Overal survival;

Countries

China

Contacts

Public ContactZhang Qiang

Liangning Cancer Hospital &Institute

zhangqiang8220@163.com+86 18900917799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026