A Phase 3 interventional study of Cholecalciferol and Inj. Progesterone in Locally Advanced Breast Cancer and Large Operable Breast Cancer, sponsored by Tata Memorial Hospital. Terminated at 1 site in India. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Tata Memorial Hospital · Phase 3, Interventional, and Treatment
Randomized Controlled Trial of Neoadjuvant Progesterone and Vitamin D3 in women with Large Operable Breast Cancer and Locally Advanced Breast Cancer - A Feasibility Study
Primary Progesterone Timing of surgery during the menstrual cycle and its impact on survival in premenopausal women with operable breast cancer has been extensively researched and reinvestigated by Badwe et al in the randomized clinical trial of 'Primary Progesterone Therapy for Operable Breast Cancer' at Tata Memorial Hospital. The underlying assumption was that the presence of unopposed estrogen (in follicular phase) at the time surgery may be deleterious for survival and that circulating progesterone might counteract this deleterious effect.
Vitamin D3 The most prominent physiological role of hormonally active form of vitamin D3, 1,25-dihydroxyvitamin D3 (1,25(OH)2D3 or calcitriol), is regulation of calcium and phosphorous homeostasis and bone metabolism via an intracellular receptor (VDR) which is a member of steroid thyroid hormone super-family of receptors. The VDR receptors are also found in other tissues like breast and prostate.
Vitamin D compounds have also been implicated in promotion of apoptosis in breast cancer cells and evidence suggests that 1,25(OH)2D3 and its synthetic analogues may potentiate responsiveness of breast cancer cells to conventional cytotoxic agents.
Objectives
Inclusion Criteria:
Exclusion Criteria:
Methodology / Treatment plan
The study drugs (Injectable Progesterone and Vitamin D3) will be tested in the neoadjuvant setting prior to administration of each chemotherapy cycle, in a 2x2 factorial design as below:
Neoadjuvant D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before each chemotherapy cycle.
Neoadjuvant Progesterone used will be administered as single IM depot injection 500mg 5 days prior to each CT cycle and surgery date.
Primary Objectives Disease-free survival
Secondary Objectives Improvements in overall survival Tumor response
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 800 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
No Injection Vit D3 or Injection Progesterone prior to chemotherapy cycle
Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Drug: Inj. Progesterone
Injection Arachitol (Vitamin D3) 300,000 I.U/ml IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Drug: Cholecalciferol
Injection Arachitol (Vitamin D3) 300,000 I.U/ml IM and Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Drug: Cholecalciferol · Drug: Inj. Progesterone
Inj Arachitol 300,000 I.U/ml IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Also known as: IArachitol
Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Also known as: Inj. Proluton Depot
Disease-free survival
Disease-free survival
Time frame: 5 years
Improvements in overall survival, Tumor response
Overall Survival
Time frame: 5 years
This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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