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

NCT00194792 | Terminated Phase 2 Results

• 2 other identifiers: 6277NCI-2010-00549
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Clinical Response

  Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.

  1 month

• Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response

  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.

  From date of treatment start to surgery

• Disease-free Survival

  Kaplan-Meier estimate assessed at 5 years

  Up to 5 years

• Overall Survival

  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.

  Up to 5 years

• Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities

  Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities

  Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)

• Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation

  Count of patients with dose reduction, treatment interruption, or treatment discontinuation.

  During adjuvant and neoadjuvant chemotherapy

Secondary Outcomes (1)

• Correlation of Molecular Markers With Response, Time to Progression, and Survival

  Weekly during CHB and XMN and pacitaxel

Study Arms (1)

Treatment (hormone therapy and chemotherapy)

EXPERIMENTAL

See detailed description

Drug: exemestane; Drug: triptorelin pamoate; Drug: capecitabine; Drug: methotrexate; Drug: vinorelbine tartrate; Drug: paclitaxel; Procedure: therapeutic conventional surgery; Radiation: radiation therapy; Other: laboratory biomarker analysis

Interventions

exemestane DRUG

Given PO

Also known as: Aromasin, FCE-24304, PNU 155971

Treatment (hormone therapy and chemotherapy)

triptorelin pamoate DRUG

Given IM

Also known as: Pamorelin, Trelstar Depot

Treatment (hormone therapy and chemotherapy)

capecitabine DRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda

Treatment (hormone therapy and chemotherapy)

methotrexate DRUG

Given IV

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Treatment (hormone therapy and chemotherapy)

vinorelbine tartrate DRUG

Given IV

Also known as: Eunades, navelbine ditartrate, NVB, VNB

Treatment (hormone therapy and chemotherapy)

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (hormone therapy and chemotherapy)

therapeutic conventional surgery PROCEDURE

Undergo lumpectomy or mastectomy

Treatment (hormone therapy and chemotherapy)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (hormone therapy and chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (hormone therapy and chemotherapy)

Eligibility Criteria

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

You may qualify if:

• Have histologically confirmed, operable ER or PR +, HER2/neu negative, radiographically measurable breast cancer \> 1cm (Operable lesions are T1c - T3 and N0 - N2a; histologic confirmation should be by core needle biopsy only)
• Be chemotherapy naive
• Have an ECOG performance status of =\< 2
• Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy \[or in whom the status of the ovaries is unknown\], with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab)
• All premenopausal patients must have a baseline FSH and LH
• ANC \>= 1,500
• Platelet count \>= 100,000
• Serum creatinine =\< 1.5 x IULN
• Estimated creatinine clearance \> 50 ml/min
• Have staging studies and tumor assessment prior to registration
• Bone density exam must be done within the first 3 months of complete hormonal blockade
• Have a negative pregnancy test within seven days prior to registration if of childbearing potential
• Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures

You may not qualify if:

• Primary tumor =\< 1 cm, not measurable; inflammatory disease
• Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded (Women of childbearing potential who are not using a reliable and appropriate contraceptive method are excluded; patients must agree to continue contraception for 30 days from the last study drug administration)
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
• Previous enrollment in an investigational drug study within the last 4 weeks
• Evidence of distant metastatic disease
• Prior chemotherapy or hormonal therapy for breast cancer
• Prior malignancy other than adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, other stage I or II cancer from which the patient has been disease free for at least 5 years
• History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake
• Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication or myocardial infarction
• Major surgery within four weeks of the start of study treatment without complete recovery
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Known, existing uncontrolled coagulopathy
• Unwillingness to give informed consent
• Unwillingness to participate or inability to comply with the protocol for the duration of the study

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Triptorelin Pamoate; Capecitabine; Methotrexate; merphos; Vinorelbine; Paclitaxel; Taxes; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Dr. Hannah Linden
• Organization: University of Washington / Seattle Cancer Care Alliance

hmlinden@uw.edu

206-288-6989

Study Officials

• Hannah Linden

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 11, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-06

Locations

US (1)