Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer

NCT01924078 | Unknown Phase 2 DMC

• 1 other identifier: Metronomic Therapy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is to determine the adverse effects and clinical efficacy of AI combined with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with Estrogen receptor and/or Progestrogen receptor positive.

Conditions

Breast Cancer

Keywords

breast cancer; metronomic chemotherapy; aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• adverse events

  adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)

  average 10 months

Secondary Outcomes (2)

• PFS

  average 10 months

• TTF

  average 10 months

Study Arms (1)

Metronomic Capecitabine and AI

EXPERIMENTAL

Postmenopausal Hormone receptor positive breast cancer patients who wanted to conserve breast were enrolled to receive capecitabine 500mg/tid p.o plus one of the aromatase inhibitors (AIs):Anastrozole 1mg/day p.o, and who had first line or second line Letrozole therapy failure were switched to capecitabine 500mg/tid p.o plus Exemestane 25mg/day p.o；or Exemestane therapy failure were switched to capecitabine 500mg/tid p.o plus Letrozole 2.5mg/day p.o.

Drug: Capecitabine; Drug: aromatase Inhibitors (AIs)

Interventions

Capecitabine DRUG

metronomic use: capecitabine 500mg/tid

Also known as: Xeloda

Metronomic Capecitabine and AI

aromatase Inhibitors (AIs) DRUG

Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.

Also known as: Exmestane or Letrozol or Anastrozol

Metronomic Capecitabine and AI

Eligibility Criteria

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

You may qualify if:

• Hormone receptor positive;
• previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure;
• patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery.
• patients with metastatic breast cancer must have evaluable lesions
• normal laboratory values:
• informed consent (ethical approval document No. :1112105-1);
• life expectancy of at least 3 months;
• Postmenopausal or premenopausal with bilateral oophorectomy.

You may not qualify if:

• have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months
• organ transplant (except for autologous or allogeneic bone marrow transplantation);
• have evidences of central nerve system metastases or have a history of mental illness that uncontrol;
• unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity;
• unwilling or unable to comply with study protocol or unable to meet the follow up;
• patients who researchers considered were not suitable to participate.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

FUSCC

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Li JW, Zuo WJ, Ivanova D, Jia XQ, Lei L, Liu GY. Metronomic capecitabine combined with aromatase inhibitors for new chemoendocrine treatment of advanced breast cancer: a phase II clinical trial. Breast Cancer Res Treat. 2019 Jan;173(2):407-415. doi: 10.1007/s10549-018-5024-3. Epub 2018 Oct 25.

  PMID: 30361875 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Aromatase Inhibitors; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles

Study Officials

• Guang-yu Liu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang-Yu Liu, MD

CONTACT

86-021-64175590; liugy123@yahoo.com

Jian-wei Li, MD

CONTACT

86-021-64175590; doctorljw@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Department of Surgical Oncology,Cancer Hospital & Institute

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: October 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

CN (1)