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A randomized, controlled, phase II clinical study on the prophylactic use of pirfenidone capsules to reduce the incidence of capsular contracture after breast reconstruction and radiotherapy in breast cancer patients

A randomized, controlled, phase II clinical study on the prophylactic use of pirfenidone capsules to reduce the incidence of capsular contracture after breast reconstruction and radiotherapy in breast cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117522
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Breast cancer patients undergoing breast reconstruction after mastectomy

Interventions

study group:Take pirfenidone orally

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18~70 years. 2.ECOG PS score < 2. 3.Breast cancer patients who have undergone total mastectomy and postoperative reconstruction. 4.Planned to receive adjuvant radiotherapy. 5.No history of other malignancies (except basal cell carcinoma of the skin). 6.Informed consent form signed before the study began.

Exclusion criteria

Exclusion criteria: 1.Clinically or radiologically confirmed presence of metastatic disease. 2.History of chest radiation therapy. 3.Combining scleroderma, active lupus erythematosus, and other autoimmune diseases. 4.Pregnant or lactating patients. 5.Combined severe cardiac, pulmonary, hepatic, renal, hematopoietic system, neurological disorders or psychiatric diseases.

Design outcomes

Primary

MeasureTime frame
Incidence of >= Baker Grade ? capsular contracture;

Secondary

MeasureTime frame
Local recurrence rate;Prosthesis loss rate.;Local regional recurrence rate;Beauty effects.;Disease free survival;Overall survival;

Countries

China

Contacts

Public ContactHonglian Ma

Zhejiang Cancer Hospital

mahl@zjcc.org.cn+86 571 8812 8172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026