Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores

NCT00832338 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB00012185WCI1505-08
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Neoplasms; Breast Cancer; Cancer of the Breast

Keywords

Breast cancer; Tumors, Breast; Cancer of the breast

Outcome Measures

Primary Outcomes (1)

• Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)

  Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging. If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.

  At time of definitive surgery

Study Arms (1)

Docetaxel with Cytoxan

EXPERIMENTAL

Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.

Drug: Docetaxel with Cytoxan; Drug: Dexamethasone

Interventions

Docetaxel with Cytoxan DRUG

Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.

Also known as: Docetaxel, Cytoxan

Docetaxel with Cytoxan

Dexamethasone DRUG

Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.

Also known as: Decadron

Docetaxel with Cytoxan

Eligibility Criteria

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

You may qualify if:

• 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.
• No prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
• Adequate organ function within 14 days of study entry:
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mm³, Hgb \> 8.0 g/dl, and platelet count ≥ 100,000/mm³.
• Hepatic function: total bilirubin \< upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT)(AST) or serum glutamic pyruvic transaminase (SGPT)(ALT) and alkaline phosphatase ≤ 1.5 x ULN.
• Renal function: calculated creatinine clearance (CrCl) ≥ 30 mL/min using the Cockroft Gault equation.

You may not qualify if:

• Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.
• 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.

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Jane Meisel, MD
• Organization: Emory University

jane.l.meisel@emory.edu

404-778-1900

Study Officials

• Elisavet Paplomata, MD

  Emory University Winship Cancer Institute

  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: January 29, 2009
• First Posted: January 30, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 31, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-08

Locations

US (3)