An assessment of effect of pre operative Proluton in patients with operable breast cancer

An assessment of the effect of preoperative hydroxyprogesterone on serial levels of circulating tumour cells and serum nucleic acids (DNA and chromatin) in patients undergoing surgery for operable breast cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/11/005229

Enrollment

100

Registered

2014-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Operable Breast Cancer

Interventions

Intervention1: Inj. Hydroxyprogesterone 500 mg: The patients will be randomized to receiving preoperative inj. Progesterone 500 mg deep IM Intervention2: Inj. Hydroxyprogesterone 500 mg: patients will

Eligibility

Inclusion criteria

Inclusion criteria: Breast cancer patients with loco-regionally confined disease planned for up front surgery shall be taken into the study. FNAC or core biopsy proven breast cancer with clinically positive axillary nodes T1-3 N1 patients will be eligible

Exclusion criteria

Exclusion criteria: 1. Prior excision biopsy 2. Patients receiving preoperative chemotherapy 3. Prior treatment for any other malignancies 4. Women who are pregnant, breast-feeding.

Design outcomes

Primary

Measure	Time frame
An assessment of the effect of preoperative hydroxyprogesterone on serial levels of circulating tumour cells and serum nucleic acids (DNA and chromatin)Timepoint: for assessment of levels of circulating tumour cells and nucleic acids (DNA and chromatin) shall be taken for all the patients at the following time points 1. Pre operative at the time of induction 2. Intra operative at the time of tumour handling 3. Post operative at the time of closure Samples for nucleic acids (DNA and chromatin) will also be collected prior to and post core biopsy.	—

Measure

Time frame

An assessment of the effect of preoperative hydroxyprogesterone on serial levels of circulating tumour cells and serum nucleic acids (DNA and chromatin)Timepoint: for assessment of levels of circulating tumour cells and nucleic acids (DNA and chromatin) shall be taken for all the patients at the following time points 1. Pre operative at the time of induction 2. Intra operative at the time of tumour handling 3. Post operative at the time of closure Samples for nucleic acids (DNA and chromatin) will also be collected prior to and post core biopsy.

—

Secondary

Measure	Time frame
No Secondary OutcomeTimepoint: No secondary outcome	—

Countries

India

Contacts

Public ContactDr Nita Nair

Tata Memorial Hospital

vaniparmar@gmail.com912224177000

Outcome results

None listed

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