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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170711001
Enrollment
154
Registered
2017-07-11
Start date
2017-07-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Locally advanced breast cancer

Interventions

4 cycles of AC (Doxorubicin&#45
60 mg/m2 Cyclophosphamide&#45
600 mg/m2) in day 1
3 weekly cycle followed by postoperative 4 cycles of Paclitaxel (175 mg/m2) ,3 cycles of FAC (5&#45
Flurouracil&#45
500 mg/m2&#44
Doxorubicin&#45
50 mg/m2&#44
Cyclophosphamide – 500 mg/m2) in day 1
3 weekly cycle followed by postoperative 3 cycles of FAC
Active Comparator Drug,Active Comparator Drug
Doxorubicin&#44
Cyclophosphamide followed by Paclitaxel,5&#45
FU&#44
Cyclophosphamide

Sponsors

Bangabandhu Sheikh Mujib Medical University
Lead Sponsor
Dr. Md. Shahed &#45
Collaborator
Ul &#45
Collaborator
Matin
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion 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

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&#44; uncontrolled diabetes mellitus&#44; 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.

Design outcomes

Primary

MeasureTime frame
Response Before surgery and end of chemotherapy RECIST criteria

Secondary

MeasureTime frame
Toxicity After each cycle of chemotherapy The National Cancer Institute‘s ‗Common Terminology Criteria for Adverse Events&#44; v.3.0‘

Countries

Bangladesh

Contacts

Public ContactShahed Matin

Bangabandhu Sheikh Mujib Medical University

md.shahed.ul.matin@gmail.com01747712152

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026