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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT00194792

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery

Detailed Description

PRIMARY OBJECTIVES: I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of complete hormonal blockade (CHB) for 2 weeks followed by four three-week cycles of Xeloda, Methotrexate and Navelbine with continuation of complete hormonal blockade. SECONDARY OBJECTIVES: I. To assess the clinical response rate in patients with surgically resectable breast cancer treated with complete hormonal blockade and four three-week cycles of Xeloda, Methotrexate and Navelbine. II. To assess the toxicity associated with these regimens. III. To assess the relapse rate, overall and disease-free survival in patients with operable breast cancer when treated with neoadjuvant CHB and XMN + CHB followed by adjuvant treatment using XMN or Taxol. IV. To assess whether the phenotype of breast cancer changes with treatment. V. To assess whether phenotypic changes in breast tumors predict outcome. OUTLINE: NEOADJUVANT CHB: Patients receive exemestane orally (PO) daily for 14 weeks. Premenopausal patients also receive triptorelin pamoate intramuscularly (IM) once monthly for 4 months beginning 2 weeks before the initiation of exemestane. NEOADJUVANT CHEMOTHERAPY: Patients receive capecitabine PO twice daily (BID) on days 1-14 and methotrexate intravenously (IV) and vinorelbine ditartrate IV over 6-10 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses. SURGERY: Patients then undergo definitive surgical resection with or without radiation therapy. ADJUVANT CHEMOTHERAPY: Patients with microscopic complete response (pCR) or disease that has been down-staged to =\< 1 cm with no positive nodes receive capecitabine PO BID on days 1-14 and methotrexate IV and vinorelbine ditartrate IV over 6-10 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses. Patients with down-staged T and 0 or 1 positive node receive paclitaxel IV over 1 hour once weekly for 12 weeks. ADJUVANT HORMONAL THERAPY: Patients receive hormonal therapy for 5 years. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Interventions

Name: exemestane
Type: DRUG
Description: Given PO
Name: triptorelin pamoate
Type: DRUG
Description: Given IM
Name: capecitabine
Type: DRUG
Description: Given PO
Name: methotrexate
Type: DRUG
Description: Given IV
Name: vinorelbine tartrate
Type: DRUG
Description: Given IV
Name: paclitaxel
Type: DRUG
Description: Given IV
Name: therapeutic conventional surgery
Type: PROCEDURE
Description: Undergo lumpectomy or mastectomy
Name: radiation therapy
Type: RADIATION
Description: Undergo radiation therapy
Name: laboratory biomarker analysis
Type: OTHER
Description: Correlative studies

Primary Outcomes

Measure: Number of Participants With Clinical Response
TimeFrame: 1 month
Description: Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
Measure: Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
TimeFrame: From date of treatment start to surgery
Description: Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.
Measure: Disease-free Survival
TimeFrame: Up to 5 years
Description: Kaplan-Meier estimate assessed at 5 years
Measure: Overall Survival
TimeFrame: Up to 5 years
Description: From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.
Measure: Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
TimeFrame: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
Description: Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
Measure: Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
TimeFrame: During adjuvant and neoadjuvant chemotherapy
Description: Count of patients with dose reduction, treatment interruption, or treatment discontinuation.

Trial Information

NCT ID

NCT00194792

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

University of Washington

Last Updated

December 15, 2025