Feasibility study of dose dense chemotherapy for primary breast cancer patients

JRCT ID: jRCTs041180139

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 31/07/2017
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Anthracycline followed by taxane

Anthracyclin (1 or 2)

1) dose dense AC (ddAC);
Day1 Doxorubicin 60 mg/m2, Cyclophosphamide 600 mg/m2
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles

2) dose dense EC (ddEC);
Day1 Epirubicin 90 mg/m2, Cyclophosphamide 600 mg/m2, day 1
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles

Taxane (3 or 4)

3) weekly Paclitaxel:
Day1 Paclitaxel 80 mg/m2
weekly, 12 cycles

4) dd-PTX:
Day1 PTX 175 mg/m2
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles

Outcome(s)

• Primary Outcome: Completion rate of treatment, safety
• Secondary Outcome: Disease free survival, overall survival, dose intensity, exploratory study to determine predictive factors of efficacy of dose dense chemotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Saito Kanako
• Secondary ID(s): UMIN000026954