To see the effect of INj proluton if given before surgery in patients with high risk operable breast cancer.Ã¢â?¬?

A Phase III Randomized Controlled study of Inj. Proluton (Hydroxyprogesterone caproate) as single dose preoperative therapy in patients with high risk operable breast cancer.Ã¢â?¬?

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005098

Enrollment

860

Registered

2014-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: null- High risk operable breast cancer

Interventions

Intervention1: Inj Proluton: Hydroxyprogesterone caproate, 500mg IM.Frequency and Duration - Single Injection progesterone 500 mg IM will be given 3-11 day prior to surgery. In case surgery is delaye

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients willing to provide informed consent. 2 Women 18 years of age or more. 3 Operable Breast cancer patients with clinically or radiologically node positive disease

Exclusion criteria

Exclusion criteria: 1 Patients with a prior history of any malignancy. 2 Patient with a prior history of excision biopsy. 3 Patient receiving preoperative chemotherapy 4 Women who are pregnant, breast-feeding.

Design outcomes

Primary

Measure	Time frame
To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on disease-free survival (DFS) at 5 years.Timepoint: 5 years	—

Secondary

Measure	Time frame
To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on overall survival (OS) at 5 yearsTimepoint: 5 yrs	—

Countries

India

Contacts

Public ContactDr Yogesh Kumar

AIIMS

svsdeo@yahoo.co.in9811356594

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026