Feasibility study of dose dense chemotherapy for primary breast cancer patients

Phase 2

• Conditions: Breast cancer

• Registration Number: JPRN-jRCTs041180139
• Lead Sponsor: Saito Kanako

Brief Summary

Thirty breast cancer patients were treated with dose-dense chemotherapy. The completion rate was 76%. The completion rate was 88% in 26 patients, excluding 3 patient requests and 1 ineligible patient among the discontinued cases. The 3 discontinuations were due to liver dysfunction in 2 cases and pneumonia in 1 case; no cases of PCP pneumonia were observed. After the completion of enrollment, doxorubicin and paclitaxel were revised in the package inserts, and this treatment is now covered by insurance.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Invasive ductal carcinoma
2. Stage I-III
3. Age >=20 and 75=<
4. ECOG PS 0 or 1
5. Vital organ functions are preserved
6. Written IC

Exclusion Criteria

1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
2. History of drug-related allergy which could hinder planned treatment
3. Any history or complication of following cardiac disorders
- History of congestive heart failure, cardiac infarction
- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
4. Poorly controlled hypertension
5. Poorly controlled diabetes
6. Pregnancy
7. Ineligible to the trial based on decision of an investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified