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Clinical research of CDK4/6-related multi-molecular function visualization in the response evaluation of neoadjuvant therapy for HR+/HER2- breast cancer

Clinical research of CDK4/6-related multi-molecular function visualization in the response evaluation of neoadjuvant therapy for HR+/HER2- breast cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066802
Enrollment
Unknown
Registered
2022-12-19
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Breast Cancer

Interventions

Different doses:1.Aromatase inhibitors+CDK4/6 inhibitors
2.18F-CDKi
3.18F-FES
Optimal dose:1.Aromatase inhibitors+CDK4/6 inhibitors

Sponsors

Xiang'an Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Postmenopausal women; 2.Stage?-?B, ER and/or PR positive and HER2 negative breast cancer confirmed by histopathology with tumor size > 2.0 cm (ultrasound); 3. Karl Fischer score = 60 or WHO physical status score 0-2; 4. No distant metastasis; 5. No history of endocrine therapy; 6. No contraindication of radiotherapy, chemotherapy and surgery; 7. No serious basic disease; 8. Sign the informed consent voluntarily; 9. Able to comply with the agreement.

Exclusion criteria

Exclusion criteria: 1.History of other malignant tumors; 2.Other serious diseases: congenital malformation, acute inflammation, cachexia, myocardial infarction and stroke within 6 months, severe liver and kidney dysfunction,etc; 3.Pregnant or lactating women (for women with complete reproductive organs and less than two years after menopause,the certificate of negative pregnancy test must be provided); 4. Have received endocrine therapy, radiotherapy, chemotherapy or surgery before treatment; 5. Participants in another clinical trial.

Design outcomes

Secondary

MeasureTime frame
Correlation between SUVmax and treatment response;

Primary

MeasureTime frame
SUVmax;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactGuojun Zhang

Xiang'an Hospital of Xiamen University

gjzhang@xah.xmu.edu.cn18850064298

Outcome results

None listed

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