Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

NCT00941330

Last updated date
Study Location
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Signed informed consent.

- Histologically or cytologically confirmed breast carcinoma.

- Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).

- 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 fluorescent in situ hybridization [FISH] non-amplified)

- Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay

- Patients must have measurable disease as defined by palpable lesion with both diameters ≥ 1 cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension ≥ 1 cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.

- 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 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

- 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 Cockcroft Gault equation.

- Patients must be at least 18 years of age.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence of disease outside the breast or chest wall, except ipsilateral axillary or
internal mammary lymph nodes.


- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast
cancer.


- 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.


- Medical, psychological or surgical condition which the investigator feels might
compromise study participation.


- 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.


- 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.


- Serious, uncontrolled, concurrent infection(s).


- 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.


- Major surgery within 28 days of study entry.


- Evidence of central nervous system (CNS) metastases.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
Official Title  ICMJE Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (? 11) and Less Than 25 (? 24)
Brief Summary The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.
Detailed Description The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane 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 or hormonal therapy before surgery, we will be able to determine if the treatment you receive is effective in treating your cancer. 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 and hormonal therapy. You will only be eligible to enter this study if the recurrence score of your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients with hormone receptor-positive breast cancers with recurrence scores less than or equal to 24 have been previously demonstrated to obtain a larger benefit from hormonal therapy, compared to chemotherapy, when these agents are given after surgery. The ability of hormonal agents and chemotherapy to shrink cancers prior to surgery has not been specifically examined in hormone receptor-positive cancers with recurrence scores less than or equal to 24.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Exemestane
    25 mg daily by mouth for 6 to 12 months.
    Other Name: Aromasin
  • Drug: Docetaxel
    Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
    Other Name: Taxotere
  • Drug: Cytoxan
    Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
    Other Name: Cyclophosphamide
Study Arms  ICMJE
  • Experimental: A: Exemestane
    ARM A: Patients will be treated with exemestane.
    Intervention: Drug: Exemestane
  • Active Comparator: B: Docetaxel and Cytoxan
    ARM B: Patients will be treated with docetaxel and cytoxan.
    Interventions:
    • Drug: Docetaxel
    • Drug: Cytoxan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2015)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
70
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent.
  • Histologically or cytologically confirmed breast carcinoma.
  • Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).
  • 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 fluorescent in situ hybridization [FISH] non-amplified)
    • Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay
  • Patients must have measurable disease as defined by palpable lesion with both diameters ? 1 cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension ? 1 cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.
  • 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 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • 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 Cockcroft Gault equation.
  • Patients must be at least 18 years of age.

Exclusion Criteria:

  • Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
  • Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
  • 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.
  • Medical, psychological or surgical condition which the investigator feels might compromise study participation.
  • 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.
  • 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.
  • Serious, uncontrolled, concurrent infection(s).
  • 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.
  • Major surgery within 28 days of study entry.
  • Evidence of central nervous system (CNS) metastases.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941330
Other Study ID Numbers  ICMJE IRB00012969
WCI1534-08 ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisavet Paplomata, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Elisavet Paplomata, MDEmory University Winship Cancer Institute
PRS Account Emory University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP