Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
Primary Purpose
Vitamin D Deficiency, Chemotherapy Effect, Pathology
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vit D
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring neoadjuvant treatment, Breast Cancer, Vitamin D3
Eligibility Criteria
Inclusion Criteria:
- Invasive breast cancer is confirmed by biopsy
- enough organ function,
- metabolically normal,
- eligible for neoadjuvant treatment
- The patients who were informed about the prerequisites with their consent
Exclusion Criteria:
- having metastatic disease
- having not operated from breast cancer after neoadjuvant treatment
Sites / Locations
- İstanbul Florence Nightingale Hospital Breast Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
study group
control group
Arm Description
The patients measured a total of 25 OH vitamin D3 levels, initial, 3'th month and 6'th month of neoadjuvant therapy with replacement treatment with vitamin D3 at least weekly 50000 IU for eight weeks.
The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3.
Outcomes
Primary Outcome Measures
pathological complete response (PCR)
No residual tumor cells both in axilla and breast
Secondary Outcome Measures
pathological complete response (PCR) relations with vitamin D levels
evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D
pathological complete response (PCR) ratio regarding molecular sub types
evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D according moleculary subtypes
Full Information
NCT ID
NCT03986268
First Posted
May 26, 2019
Last Updated
July 20, 2020
Sponsor
Florence Nightingale Hospital, Istanbul
1. Study Identification
Unique Protocol Identification Number
NCT03986268
Brief Title
Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
Official Title
The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Patients Treated With Neoadjuvant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Anticipated)
Study Completion Date
December 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florence Nightingale Hospital, Istanbul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neoadjuvant therapy according to different molecular sub types. Because of no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer.
Detailed Description
Calcitriol, a vitamin D metabolite, inhibits cell proliferation and pathways in invitro experiments. Vitamin D affects gene expression related to breast cancer and prevents cell differentiation, growth and angiogenesis . Low vitamin D may include a high risk of breast cancer, but there are also studies reporting that patients with low vitamin D levels at the time of diagnosis show more aggressive breast cancer course . Breast cells can produce vitamin D by taking part in the formation of 1,25 OH vit D3 in vitamin D synthesis as well as in kidney cells. Apoptosis can be caused by vitamin D receptors . There are very few studies on the effect of vitamin D replacement on breast cancer-related survival. There are studies reporting the incidence of fewer breast cancer with vitamin D replacement in contrast to there are studies showing the opposite .Patients achieved pathological complete response (PCR) with neoadjuvant therapy have been shown to have better survival. There are studies showing that they do not affect the PCR ratio related to the level of vitamin D in breast cancer patients receiving neoadjuvant chemotherapy. In one study, it was shown that it increases the response rate when given with bisphosphonate .There is no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer. The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neo-adjuvant therapy according to different molecular subtypes of biopsy-diagnosed breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Chemotherapy Effect, Pathology
Keywords
neoadjuvant treatment, Breast Cancer, Vitamin D3
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The patients had measured a total of 25 OH vit D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamine D3, as a control group, were planned to be compared with 30-50 patient in study groups at baseline and / or at the end of the treatment period. The pathological response rates of both groups were planned to be evaluated according to the molecular subtypes.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Active Comparator
Arm Description
The patients measured a total of 25 OH vitamin D3 levels, initial, 3'th month and 6'th month of neoadjuvant therapy with replacement treatment with vitamin D3 at least weekly 50000 IU for eight weeks.
Arm Title
control group
Arm Type
Other
Arm Description
The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3.
Intervention Type
Drug
Intervention Name(s)
Vit D
Other Intervention Name(s)
Vitamin D3, cholecalciferol
Intervention Description
The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.
Primary Outcome Measure Information:
Title
pathological complete response (PCR)
Description
No residual tumor cells both in axilla and breast
Time Frame
an average 24 weeks
Secondary Outcome Measure Information:
Title
pathological complete response (PCR) relations with vitamin D levels
Description
evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D
Time Frame
an average 24 weeks
Title
pathological complete response (PCR) ratio regarding molecular sub types
Description
evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D according moleculary subtypes
Time Frame
an average 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Invasive breast cancer is confirmed by biopsy
enough organ function,
metabolically normal,
eligible for neoadjuvant treatment
The patients who were informed about the prerequisites with their consent
Exclusion Criteria:
having metastatic disease
having not operated from breast cancer after neoadjuvant treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Çetin Ordu, Assoc.Prof
Phone
+902122883400
Email
cetinordu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Aktepe, Prof
Phone
+902122883400
Email
fatma.aktepe@florence.com.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çetin Ordu, Assoc. Prof
Organizational Affiliation
Gayrettepe FN Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma Aktepe, Prof
Organizational Affiliation
Gayrettepe FN Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vahit Özmen, Prof
Organizational Affiliation
İstanbul FN hospital
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul Florence Nightingale Hospital Breast Health Center
City
Istanbul
State/Province
Şişli
ZIP/Postal Code
34450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Çetin Ordu, Assoc.Prof
Phone
+902122883400
Email
cetinordu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Fatma Aktepe, Prof
Phone
+902122883400
Email
fatma.aktepe@florence.com.tr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The aim of the study was to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing biopsy-diagnosed neo-adjuvant therapy according to different molecular subtypes.
Citations:
PubMed Identifier
24719175
Citation
Clark AS, Chen J, Kapoor S, Friedman C, Mies C, Esserman L, DeMichele A; I-SPY1 Investigators. Pretreatment vitamin D level and response to neoadjuvant chemotherapy in women with breast cancer on the I-SPY trial (CALGB 150007/150015/ACRIN6657). Cancer Med. 2014 Jun;3(3):693-701. doi: 10.1002/cam4.235. Epub 2014 Apr 9.
Results Reference
result
PubMed Identifier
22234628
Citation
Shao T, Klein P, Grossbard ML. Vitamin D and breast cancer. Oncologist. 2012;17(1):36-45. doi: 10.1634/theoncologist.2011-0278. Epub 2012 Jan 10.
Results Reference
result
PubMed Identifier
18711029
Citation
Rossi M, McLaughlin JK, Lagiou P, Bosetti C, Talamini R, Lipworth L, Giacosa A, Montella M, Franceschi S, Negri E, La Vecchia C. Vitamin D intake and breast cancer risk: a case-control study in Italy. Ann Oncol. 2009 Feb;20(2):374-8. doi: 10.1093/annonc/mdn550. Epub 2008 Aug 18.
Results Reference
result
PubMed Identifier
17927502
Citation
Abbas S, Linseisen J, Chang-Claude J. Dietary vitamin D and calcium intake and premenopausal breast cancer risk in a German case-control study. Nutr Cancer. 2007;59(1):54-61. doi: 10.1080/01635580701390223.
Results Reference
result
PubMed Identifier
11146455
Citation
Levi F, Pasche C, Lucchini F, La Vecchia C. Dietary intake of selected micronutrients and breast-cancer risk. Int J Cancer. 2001 Jan 15;91(2):260-3. doi: 10.1002/1097-0215(200002)9999:99993.3.co;2-r.
Results Reference
result
PubMed Identifier
30060745
Citation
Viala M, Chiba A, Thezenas S, Delmond L, Lamy PJ, Mott SL, Schroeder MC, Thomas A, Jacot W. Impact of vitamin D on pathological complete response and survival following neoadjuvant chemotherapy for breast cancer: a retrospective study. BMC Cancer. 2018 Jul 30;18(1):770. doi: 10.1186/s12885-018-4686-x.
Results Reference
result
PubMed Identifier
11158062
Citation
Zehnder D, Bland R, Williams MC, McNinch RW, Howie AJ, Stewart PM, Hewison M. Extrarenal expression of 25-hydroxyvitamin d(3)-1 alpha-hydroxylase. J Clin Endocrinol Metab. 2001 Feb;86(2):888-94. doi: 10.1210/jcem.86.2.7220.
Results Reference
result
Learn more about this trial
Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy
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