Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054275
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 13, 2012
Last Update Posted : February 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paula Silverman, MD, Case Comprehensive Cancer Center

February 5, 2003
February 6, 2003
February 21, 2012
March 13, 2012
February 17, 2016
December 2002
April 2010   (Final data collection date for primary outcome measure)
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000 [ Time Frame: after 6 course (6 months) of combination therapy ]
Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
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Complete list of historical versions of study NCT00054275 on Archive Site
  • Progression Free Survival(PFS) [ Time Frame: 3 years ]
    Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
  • Overall Survival as of 2008 [ Time Frame: 5 yrs ]
    Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.
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Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.


  • Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer.
  • Determine time to tumor progression in patients treated with this regimen.
  • Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib.

OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: docetaxel
    Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.
    Other Names:
    • Taxotere
    • RP 56976
    • NSC #628503
  • Drug: erlotinib hydrochloride
    OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.
    Other Names:
    • CP-358
    • 774
    • USAN: erlotinib hydrochloride
    • Tarceva
Experimental: Erlotinib Plus Docetaxel
  • Drug: docetaxel
  • Drug: erlotinib hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2012
April 2010   (Final data collection date for primary outcome measure)


  • Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
  • Measurable disease
  • Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel
  • Stable brain metastases allowed
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG (Eastern Cooperative Oncology Group) 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 6 months


  • WBC(White Blood Count) at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 8 g/dL


  • Bilirubin normal
  • AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min
  • No clinically significant proteinuria
  • No significant impairment of renal function


  • No New York Heart Association class III or IV heart disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No inadequately controlled hypertension


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
  • No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer
  • No ongoing or active infection
  • No peripheral neuropathy greater than grade 1
  • No other concurrent uncontrolled medical condition that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • Prior trastuzumab (Herceptin) allowed


  • See Disease Characteristics
  • No prior chemotherapy for recurrent or metastatic disease
  • Prior adjuvant chemotherapy allowed

Endocrine therapy

  • Prior hormonal therapy allowed


  • Not specified


  • Not specified


  • No other concurrent investigational agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA043703 ( U.S. NIH Grant/Contract )
07-02-14M ( Other Identifier: University Hospitals IRB )
CASE-CWRU-1102 ( Other Identifier: Case Comprehensive Cancer Center )
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Paula Silverman, MD, Case Comprehensive Cancer Center
Paula Silverman, MD
National Cancer Institute (NCI)
Principal Investigator: Paula Silverman, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
February 2016

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