An Observational Study to Assess Response to Tamoxifen in Breast Cancer Patients

NCT00965939 | Completed DMC

• 2 other identifiers: S51257B32220095818
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

Brief Summary

CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria, between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of tamoxifen use. The TAS score is based on the presence of genetic variations and drug interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.

Conditions

ER-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  3 months/ 6 months

Secondary Outcomes (4)

• TTP

  3 months/ 6 months

• clinical benefit (CR + PR + SD ≥ 6 months)

  3 months/6months

• Endometrial thickness and uterine volume

  Baseline/ 3 months

• Tolerability of tamoxifen-HRQoL questionnaire

  baseline/ 3months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female, with ER-positive breast cancer

You may qualify if:

• \- Female \> 18 years of age
• Written and voluntary informed consent understood signed and dated
• Histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast either large (cT3), locally advanced stage IIIB/C inoperable, or metastatic and not amenable to curative therapy with surgery or radiotherapy.
• Measurable disease is defined as follows: CT scan for metastatic or locally advanced stage IIIB disease and ultrasound of the breast for operable large size breast cancers where tamoxifen is given for neoadjuvant endocrine therapy .
• Patients must be postmenopausal as defined by criteria in appendix 1.
• Breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
• Prior endocrine tamoxifen therapy in the adjuvant setting is allowed if there is more than 12 months after completion of adjuvant tamoxifen.
• Prior radiotherapy is allowed but evaluable lesions that have been irradiated need to be progressive before starting in the study
• Concurrent use of bisphosphonates is allowed if they are started 2 weeks before study start and these drugs should be continued as planned throughout the study
• Adequate renal and liver function Serum creatinine and serum bilirubin ≤ 1.5 X ULN Serum ALT and AST ≤ 2.5 X ULN (or ≤ 5 in case of liver metastases)
• Serum calcium should be ≤ 11,6 mg/dl
• ECOG performance status 0,1,2 (appendix 2)

You may not qualify if:

• \- Male
• Life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
• CNS involvement
• Less than 12 months since stopping tamoxifen in the adjuvant setting
• Previous chemotherapy, tamoxifen or more than one line hormone therapy or targeted therapy for locally advanced/ metastatic breast cancer
• Bone lesions only
• One line of prior endocrine therapy with an oral aromatase inhibitor for locally advanced or metastatic breast cancer is not allowed also not if there is clear progression according to RECIST and the clinician judges tamoxifen an appropriate second line therapy
• Contra indication for tamoxifen: history of DVT/vaginal bleeding of unknown origin
• Dementia
• History of other malignancy that may interfere with at least 6 months of tamoxifen therapy

Sponsors & Collaborators

• Vlaamse Vereniging voor Obstetrie en Gynaecologie: lead

Study Sites (12)

Imelda ziekenhuis

Bonheiden, Antwerpen, 2820, Belgium

Location

AZ St-Maarten Campus Rooienberg

Duffel, Antwerpen, 2570, Belgium

Location

Heilig-Hartziekenhuis

Lier, Antwerpen, 2500, Belgium

Location

Ziekenhuizen Oost-Limburg campus St-jan

Genk, Limburg, 3600, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

AZ St-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

Maria-Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ St-Nikolaas

St-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Heilig-Hartziekenhuis

Roeselare, West-Vlaanderen, 8800, Belgium

Location

UCL

Brussels, 1200, Belgium

Location

Study Officials

• Patrick Neven

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 26, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

BE (12)