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Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores

Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25

NCT00832338•Emory University

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

Detailed Description

Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow you to have less extensive surgery by shrinking the size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy. You will only be eligible to enter this study if the recurrence score determined using the Oncotype DX assay is 25 or greater. Patients with hormone receptor-positive breast cancers with recurrence scores greater than or equal to 25 have been previously demonstrated to obtain a significant benefit from chemotherapy given after surgery. In addition, researchers would like to examine proteins present in your blood and proteins present in your breast tissue. These additional parts of the study are voluntary and are NOT required to participate in this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent.
•Histologically or cytologically confirmed breast carcinoma.
•Early stage breast cancer (T1c-3, clinically node-negative-3 \[cN0-3\], cM0).
•No evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
•Pre-treatment biopsy with the following characteristics:
•* Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)
•* HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be fluorescence in situ hybridization \[FISH\] non-amplified)
•* Recurrence score ≥ 25 using Oncotype DX 21-gene assay
•Patients must have measurable disease as defined by palpable lesion with both diameters ≥ 1cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension ≥ 1cm. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
+6 more criteria

Exclusion Criteria

•No medical, psychological or surgical condition which the investigator feels might compromise study participation.
•No patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
•No evidence of peripheral or sensory neuropathy.
•Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.
•No serious, uncontrolled, concurrent infection(s).
•No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.
•No major surgery within 28 days of study entry.
•No evidence of central nervous system (CNS) metastases.

Locations (3)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

August 31, 2017

Enrollment

ACTUAL participants

Conditions

Breast NeoplasmsBreast CancerCancer of the Breast

Interventions

Docetaxel with Cytoxan

DRUG

Dexamethasone

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores

Inclusion Criteria

Exclusion Criteria

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