Progesterone and Vitamin D3 in Women With LOBC and LABC - A Feasibility Study

This study is currently recruiting participants.
Verified June 2013 by Tata Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01608451
First received: May 22, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

Timing of surgery during the menstrual cycle and its impact on survival in pre-menopausal 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 timing of surgery during the menstrual cycle and survival in breast cancer carries two distinct postulates. First, hormonal milieu in the host can modulate metastatic potential of breast cancer and second, events at the time of surgery can influence survival. In light of the interim results of the randomized trial of primary progesterone in women with operable breast cancer showing a significant difference in the node positive high risk tumors (SABCS,2009,Abstract no.72), it is logical to now test the role of primary progesterone in large operable and locally advanced breast cancer.

The active metabolite of vitamin D3, 1,25-dihydroxyvitamin D3 (1,25(OH)2D3), has been recognized for over 2 decades as a modulator of cell proliferation and differentiation (cytotoxic and anti-proliferative) in many cell types, including breast cancer. However, it is still unclear as to how 1,25(OH)2D3 and its synthetic analogues act within breast cancer cells to elicit the effects on cellular proliferation and differentiation.[6] Vitamin D3 has been shown to decrease tumor growth in animal models[7] and is now in Phase I clinical trials for human cancers. [8] Based on these observations it is proposed to test the role of vitamin D3 in the neoadjuvant setting as a negative growth regulator and potentiator of chemotherapy by evaluation of tumor response.


Condition Intervention Phase
Breast Cancer
Locally Advanced Malignant Neoplasm
Drug: Cholecalciferol
Drug: Inj. Progesterone
Drug: Doxyrubicin or Epirubicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With LOBC and LABC - A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Disease-free survival


Secondary Outcome Measures:
  • Improvements in overall survival, Tumor response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall Survival


Estimated Enrollment: 800
Study Start Date: September 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No additional treatment
4 cycles of Neoadjuvant Chemotherapy followed by surgery.
Drug: Doxyrubicin or Epirubicin
Doxyrubicin - 50mg/m2, 4 cycles (every 21 days) OR Epirubicin - 90mg/m2, 4 cycles (every 21 days)
Other Name: Adriamycin or Epirubicin
Experimental: Inj. Proluton
Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Drug: Inj. Progesterone
Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Other Name: Inj. Proluton Depot
Experimental: Inj. Arachitol
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
300,000 I.U/ml IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Other Name: Inj.Arachitol
Experimental: Inj. Proluton plus Inj. Arachitol
Injection Arachitol (Vitamin D3) 300,000 I.U/ml IM plus Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Drug: Cholecalciferol
300,000 I.U/ml IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Other Name: Inj.Arachitol
Drug: Inj. Progesterone
Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
Other Name: Inj. Proluton Depot

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral breast cancer
  • Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast cancer/LABC (T3N1-2M0; T2N2M0)
  • Age <70 years
  • Fit for CT

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608451

Contacts
Contact: Dr. Rajendra A Badwe, MS +91-022-2417-7000 ext 7299 badwera@gmail.com
Contact: Dr. Vani Parmar, MS, DNB +91-022-2417-7000 ext 7299 vaniparmar@gmail.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Principal Investigator: Rajendra A Badwe, MS (Surgery)         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Rajendra A Badwe, MS (Surgery) Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai 400 012
Principal Investigator: Vani Parmar, DNB Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai-12
  More Information

Publications:

Responsible Party: Dr Rajendra A. Badwe, Principal Investigator, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01608451     History of Changes
Other Study ID Numbers: Vitamin D3/377/TMH, TMH project No. 377
Study First Received: May 22, 2012
Last Updated: June 18, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
Inj. Vitamin D3
Inj. Progesterone
LABC
LOBC

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Epirubicin
17-alpha-hydroxy-progesterone caproate
Progesterone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on April 15, 2014