Overall Survival and Disease-free Survival in Breast Cancer Patients Under COS

Breast Cancer Clinical Trial

Official title:

Retrospective Cohort Study of Overall Survival and Disease-free Survival in Breast Cancer Patients Who Underwent Controlled Ovarian Stimulation (COS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02745262
• Other study ID #: 1405-VIG-030-EM
• Status: Active, not recruiting
• Phase: N/A
• First received: April 13, 2016
• Last updated: April 15, 2016
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2016
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS.

Description:

Breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. As in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. Ovarian stimulation for fertility preservation is performed in this study, in patients with stage I-II (TNM) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated.

Among young women there is a greater incidence of basal type tumors and HER2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. In early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence).

It is a study that aims to collect data retrospectively from 2008 to 31 December 2015. To this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. Four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 December 2014 and patients followed until 31 December 2015. Each patient is called in order to request data authorization, to complete and track information.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age under 40 years ( at the time of diagnosis)

• TNM stage I- II

• Authorization of the fertility preservation multidisciplinary committee

Exclusion Criteria:

• Contraindications for pregnancy

• previous history of infertility

• Previous history of ovarian surgery

• Prior chemotherapy

• History of pelvic radiation

• Diabetes Mellitus

• Hypertension

• renal failure

• liver failure

• autoimmune disease.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Collect retrospectively the follow-up data
Collect retrospectively the follow-up data. Each patient is called in order to request data authorization, to complete and track information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Vigo

References & Publications (3)

Cobo A, Garcia-Velasco JA, Domingo J, Remohí J, Pellicer A. Is vitrification of oocytes useful for fertility preservation for age-related fertility decline and in cancer patients? Fertil Steril. 2013 May;99(6):1485-95. doi: 10.1016/j.fertnstert.2013.02.05 — View Citation

Frydman R, Grynberg M. Introduction: Female fertility preservation: innovations and questions. Fertil Steril. 2016 Jan;105(1):4-5. doi: 10.1016/j.fertnstert.2015.10.035. Epub 2015 Nov 21. — View Citation

Oktay K, Rodriguez-Wallberg K, Munster P. Ovarian protection during adjuvant chemotherapy. N Engl J Med. 2015 Jun 4;372(23):2268-9. doi: 10.1056/NEJMc1504241#SA2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		Up to 60 months	No