Neo-adjuvant Progesterone and Vitamin D3 in Breast cancer

Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in women with LOBC and LABC - Feasibility Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003788

Enrollment

120

Registered

2013-06-27

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- Locally Advanced Breast Cancer and Large Operable Breast Cancer

Interventions

Intervention1: Vitamin D3: Neo-adjuvant Vitamin D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before each chemotherapy cycle and surgery date. Intervention2: Inj Progestrone

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: -Unilateral breast cancer -Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast cancer/LABC (T3N1-2M0; T2N2M0) -Age -Fit for CT

Exclusion criteria

Exclusion criteria: Exclusion Criteria: -Prior IB or EB -Metastatic breast cancer -Renal failure or deranged RFT -Hypoparathyroidism -Pregnant or lactating mothers or women of childbearing age not practicing contraception -Patient on any of the following drugs: Magnesium-containing antacids, Digitalis, Phenytoin barbiturates, Thiazide diuretics. -Previous history of other cancers except cured skin and cervical carcinoma in situ.

Design outcomes

Primary

Measure	Time frame
Disease-free survivalTimepoint: 5 years	—

Secondary

Measure	Time frame
-Improvements in overall survival -Tumor response Timepoint: 5 Years	—

Countries

India

Contacts

Public ContactMs Rohini Hawaldar

Tata Memorail Centre

badwera@gmail.com022-24168601

Outcome results

None listed

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