Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

NCT00684216 | Terminated Phase 2

• 2 other identifiers: N07MANEudract 2007-007030-20
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.

Conditions

Breast Cancer

Keywords

metastatic; ER positive; PD during/after first line hormonal treatment

Outcome Measures

Primary Outcomes (1)

• Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30

  every 6 weeks

Secondary Outcomes (1)

• Time to second progression and quality of life adjusted time to 2nd recurrence.

  at the end of the study

Study Arms (2)

1

ACTIVE COMPARATOR

capecitabine followed by hormonal treatment

Drug: capecitabine; Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

2

ACTIVE COMPARATOR

hormonal treatment followed by capecitabine

Drug: capecitabine; Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)

Interventions

capecitabine DRUG

200 mg, BID, PO, QD until progression of disease

1; 2

hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) DRUG

either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

1; 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Proven infiltrating breast cancer with distant metastases or inoperable locally advanced disease.
• Positive estrogen receptor (≥ 10% positive nuclei at immunohistochemistry). Progesterone and HER-2 neu receptor have to be known.
• \- Progressive disease during first line hormonal therapy (either tamoxifen or aromatase inhibitor) for metastatic or inoperable locally advanced disease. Simultaneous use of LH-RH analogs is allowed. OR - Recurrence of disease (M1) during adjuvant hormonal therapy (either tamoxifen or aromatase inhibitor).
• No prior chemotherapy for metastatic disease
• Willing and able to participate in Quality of Life investigation -

You may not qualify if:

• Other malignancy except carcinoma in situ, unless the other malignancy was treated 5 or more years ago with curative intent without the use of chemotherapy or radiation therapy.
• Pregnancy or breast feeding women.
• Contra-indications to the use of capecitabine
• Known CNS metastases

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

NKI-AVL

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine; Tamoxifen; exemestane; Anastrozole; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles

Study Officials

• Sjoerd Rodenhuis, MD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 14, 2017

Record last verified: 2012-05

Locations

NL (1)