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Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

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ClinicalTrials.gov Identifier: NCT00130507
Recruitment Status : Terminated (A new alternative treatment caused the decrease in the rhythm of recruitment and finally termination of the trial.)
First Posted : August 15, 2005
Last Update Posted : October 26, 2011
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks. HER2 status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample size in each arm has been estimated with the Fleming method. Previous data show a clinical benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are needed.

This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36 patients are needed to choose, with a 90% of probability to be right, the best treatment arm, providing it increases benefit rate at least by 15%.

Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment arm.

Patients will be stratified as per investigational site, and presence of visceral metastatic lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive 2 cycles. If no disease progression is detected, treatment must continue until progression or unbearable toxicity.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Control Group Drug: Experimental Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line Treatment for HER2 Positive Breast Cancer Patients With Locally Advanced or Metastatic Disease, Progressing to a Previous Therapy Line With Trastuzumab and Taxanes
Study Start Date : November 2005
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A
VX (vinorelbine and capecitabine)
Drug: Control Group
Vinorelbine 25 mg/m2 iv days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, p.o., b.i.d. days 1-14 each cycle (21 days).
Experimental: Arm B
Vinorelbine and capecitabine plus trastuzumab(VXH)
Drug: Experimental
Trastuzumab, 4 mg/kg (charge dose in first week); Later 2 mg/kg iv. in following weeks plus Vinorelbine 25 mg/m2 iv days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, p.o., b.i.d. days 1-14 each cycle (21 days).

Primary Outcome Measures :
  1. Clinical benefit rate (lasting for at least 24 weeks)

Secondary Outcome Measures :
  1. Time to progression
  2. Overall response rate
  3. Response duration
  4. Safety profile
  5. Overall survival
  6. Quality of life
  7. Election of best treatment arm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Women older than 18 years old.
  • HER2 positive breast cancer with histological diagnoses.
  • Non-operable locally advanced or metastatic disease, previously treated with trastuzumab and taxanes.
  • Measurable or non-measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
  • Disease progression during or after treatment with trastuzumab and taxanes.
  • Maximum of 1 previous chemotherapy line for advanced or metastatic disease.
  • Previous radiotherapy is allowed if radiated area is not the only documented lesion.
  • At least 4 weeks since the last administration of antineoplastic treatment and all toxicities resolved.
  • Performance status Eastern Cooperative Oncology Group (ECOG) >=2.
  • Life expectancy of at least 12 weeks.
  • Left Ventricular Ejection Fraction (LVEF) evaluation (>=50%) in previous 4 weeks.
  • Hematology:

    • neutrophils >=1.5 x 10e9/l;
    • platelets >= 100 x 10e9/l;
    • hemoglobin >= 10 mg/dl
  • Hepatic function:

    • total bilirubin <= 1.5 xUNL;
    • SGOT and SGPT and alkaline phosphatase <= 2.5xUNL, or <=5xUNL if hepatic lesions present
  • Renal function:

    • creatinine <= 175 µmol/l (2 mg/dl);
    • creatinine clearance >= 60 ml/min.
  • Patients able to comply with treatment and follow-up.
  • Negative pregnancy test in the previous 14 days. Adequate contraceptive method during treatment and up to 3 months after finalised.
  • Brain metastatic lesions are allowed provided all other criteria are met.
  • Male who met inclusion criteria are eligible.

Exclusion Criteria:

  • History of hypersensitivity to vinorelbine, trastuzumab, rat proteins or trastuzumab components.
  • History of dyspnea at rest, or chronic oxygen therapy required.
  • Active infection.
  • Second malignancy, except for cervical in situ carcinoma, basal skin carcinoma, adequately treated. Previous malignancies with a 5 year disease free survival are allowed.
  • Pregnant or lactating women.
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled HA or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer, unstable diabetes mellitus.
  • Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.
  • Concomitant treatment with other therapy for cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130507

Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Hoffmann-La Roche
Study Chair: Monserrat Muñoz, MD.,PhD. Spanish Breast Cancer Research Group

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00130507     History of Changes
Other Study ID Numbers: GEICAM 2004-06
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Spanish Breast Cancer Research Group:
HER2 positive breast cancer.
Progression to trastuzumab and taxanes.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators