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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: capecitabine Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Exemestane Letrozole Anastrozole Capecitabine

U.S. FDA Resources

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:

Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30 [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to second progression and quality of life adjusted time to 2nd recurrence. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2013
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 capecitabine followed by hormonal treatment	Drug: capecitabine 200 mg, BID, PO, QD until progression of disease Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease
Active Comparator: 2 hormonal treatment followed by capecitabine	Drug: capecitabine 200 mg, BID, PO, QD until progression of disease Drug: hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole) either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Detailed Description:

This is a randomized phase II/II study. Patients are randomized for the sequence capecitabine-hormonal therapy versus hormonal therapy- capecitabine. At progression the patient should receive the other protocol treatment (e.g. if the patient was randomized to capecitabine, at progression the treatment should be switched to hormonal treatment).

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 -

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684216

Locations

Netherlands
NKI-AVL
Amsterdam, Netherlands, 1066 CX

Sponsors and Collaborators

The Netherlands Cancer Institute

Investigators

Principal Investigator:

Sjoerd Rodenhuis, MD

NKI-AvL

More Information

No publications provided

Responsible Party:	S. Rodenhuis, MD, NKI-AVL
ClinicalTrials.gov Identifier:	NCT00684216 History of Changes
Other Study ID Numbers:	N07MAN, Eudract 2007-007030-20
Study First Received:	May 22, 2008
Last Updated:	May 10, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:

metastatic
ER positive
PD during/after first line hormonal treatment

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Exemestane
Letrozole
Capecitabine
Fluorouracil
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013