Gene mutation profiling of residual lesions after neoadjuvant chemotherapy in hormone receptor positive early breast cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900028630

Enrollment

Unknown

Registered

2019-12-29

Start date

2019-12-28

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

breast cancer

Interventions

Case series:Nil

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign up inform consent form; 2. female over eighteen years old; 3. clinical tumor stage T2-T4, stage II-III,non-metastasis invasive ductal carcinoma breast cancer(confirmed by core biopsy); 4. immunohistochemical: estrogen receptor >=1% or progesterone receptor >= 1%, human epidermal growth factor receptor-2 negative; 5. not receive chemotherapy, endocrine therapy, surgery or radiotherapy before; 6. color echocardiography indicates that cardiac ejection fraction is within the normal range; 7. Eastern Cooperative Oncology Group (ECOG) scale physical condition <= 0-2 grade; 8. good organ function. 9. Finish the neoadjuvant chemotherapy and recieve the operation.Postoperative pathology indicated residual invasive carcinoma or carcinoma in situ of breast or axillary lymph nodes.

Exclusion criteria

Exclusion criteria: 1. Breast cancer with distant metastasis; 2. a history of other malignant tumors within 5 years or a history of multiple cancers; 3. patients with malignant hypertension, congestive heart failure, coronary artery failure, arrhythmia requiring treatment, and/or myocardial infarction more than 6 months old; 4. severe liver dysfunction, Child-Pugh C; 5. severe renal dysfunction; 6. intellectual abnormalities or any mental illness that interferes with the understanding of informed consent; 7. patients who are pregnant or have planned parenthood or who are breastfeeding; 8. coagulation dysfunction; 9. for any other reason, investigators or testers determine that patients are not eligible for inclusion.

Design outcomes

Primary

Measure	Time frame
Construction of gene mutation profile of residual lesions after neoadjuvant chemotherapy in HR+/HER2- breast cancer;	—

Secondary

Measure	Time frame
Factors associated 5-year disease-free survival after surgery;Factors associated 5-year overall survival after surgery;The decision rate of treatment is changed by the result of gene test;	—

Countries

China

Contacts

Public ContactGong Chang

Breast Tumor Center, Sun Yat-Sen Memorial Hospital

changgong282@163.com+86 13925089353

Outcome results

None listed

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