Doxorubicin, Cyclophosphamide followed by Paclitaxel vs. 5-FU, Doxorubicin, Cyclophosphamide in locally advanced Breast Cancer

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170711001
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: Bangabandhu Sheikh Mujib Medical University
• Public title: Doxorubicin, Cyclophosphamide followed by Paclitaxel vs. 5-FU, Doxorubicin, Cyclophosphamide in locally advanced Breast Cancer
• Scientific title: Doxorubicin, Cyclophosphamide followed by Paclitaxel vs. 5-FU, Doxorubicin, Cyclophosphamide in locally advanced Breast Cancer
• Date of first enrolment: 15/07/2017
• Target sample size: 154
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170711001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 4

Countries of recruitment

Bangladesh

Contacts

• Name: Shahed Ul Matin
• Affiliation: Bangabandhu Sheikh Mujib Medical University

• Name: Shahed Ul Matin
• Affiliation: Bangabandhu Sheikh Mujib Medical University

Key inclusion & exclusion criteria

Inclusion criteria: Patients willing to be included in this study.
ï‚· Histopathologically proven invasive ductal carcinoma.
ï‚· No prior chemotherapy, radiotherapy or breast surgery.
ï‚· Patients are required to have Eastern Co-operative Oncology Group (ECOG) performance
status up to scale 2.
ï‚· Female sex.
ï‚· Patients without distant metastasis.
Exclusion criteria: Pregnant or lactating woman.
ï‚· Patients dropped out or lost to follow up before completion of study.
ï‚· Serious concomitant medical illness including severe heart disease, uncontrolled diabetes
mellitus, or hypertension.
ï‚· Life expectancy < 6 months.
ï‚· Male sex.
ï‚· Initial surgery (excluding diagnostic biopsy) of the primary site.
ï‚· Patients with distant metastasis.
ï‚· Patients with double primaries.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Locally advanced breast cancer

Intervention(s)

Active Comparator Drug,Active Comparator Drug

4 cycles of AC (Doxorubicin- 60 mg/m2 Cyclophosphamide- 600 mg/m2) in day 1; 3
weekly cycle followed by postoperative 4 cycles of Paclitaxel (175 mg/m2) ,3 cycles of FAC (5-Flurouracil- 500 mg/m2, Doxorubicin- 50 mg/m2, Cyclophosphamide –
500 mg/m2) in day 1; 3 weekly cycle followed by postoperative 3 cycles of FAC

Doxorubicin, Cyclophosphamide followed by Paclitaxel,5-FU, Doxorubicin, Cyclophosphamide

Primary Outcome(s)

Response Before surgery and end of chemotherapy RECIST criteria

Secondary Outcome(s)

Toxicity After each cycle of chemotherapy The National Cancer Institute‘s ‗Common Terminology Criteria for Adverse Events, v.3.0‘

Secondary ID(s)

Nil known,TCTR20170711001

Source(s) of Monetary Support

Bangabandhu Sheikh Mujib Medical University

Secondary Sponsor(s)

Dr. Md. Shahed - Ul - Matin

Ethics review

Status: Submitted, approved
Approval date:
Contact:

n/a

Institutional Review Board of Bangabandhu Sheikh Mujib Medical University

n/a Ext. n/a

n/a

Results

• Date Completed: 15/03/2018