Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer (OVINTRA)

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: NCT01242449
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

This phase II study will investigate oral vinorelbine 90 mg/m2 on days 1 + 8 at 3 weeks intervals in combination with trastuzumab as 1st and 2nd line treatment of women with metastatic HER2 positive breast cancer.

Oral vinorelbine has shown the same overall response rate as i.v. vinorelbine in metastatic breast cancer, and capsules are generally better tolerated.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Drug: Vinorelbine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer
Study Start Date : November 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Trastuzumab
    Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks
  • Drug: Vinorelbine
    Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Every 9 weeks. Up to 2 years ]
    CT scan and MUGA scan

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every 9 weeks from date of first treatment until progression or death. Up to 2 years ]
    CT scan

  2. Overall Survival [ Time Frame: From date of inclusion until date of death. Up to 2 years. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Woman ≥ 18 years of age.
  • PS 0-2. Expected lifetime of more than 12 weeks.
  • Histologically verified breast cancer(adenocarcinoma)
  • Primary tumor or metastasis is HER2 positive with IHC3+ or FISH+ (ratio ≥ 2.2).
  • Documented metastatic breast cancer with min. one lesion measureable according to the RECIST 1.1 criteria. All solitary lesions must be verified cytologically/histologically if representing the only evidence of malignancy.
  • The patient may have received (neo-) adjuvant chemotherapy (taxanes, anthracyclines and trastuzumab) and 1st line chemotherapy in combination with trastuzumab for metastatic disease.
  • The patient may have received previous adjuvant antihormonal treatment for metastatic breast cancer.
  • The patient may receive radiation therapy, however, not against lesions used for response evaluation.
  • Normal heart function, LVEF ≥ 50% measured by MUGA/EKKO.
  • Normal bone marrow function: Hemoglobin ≥ 6 mmol/l, ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  • Normal liver function: Bilirubin ≤ 1.5 x upper normal level, ALAT ≤ 2.5 x upper normal level, BASP ≤ 2.5 x upper normal level (≤ 5 if presence of bone metastases).
  • Normal renal function: Creatinine ≤ upper normal level. In case of raised creatinine the measured/calculated GFR must be ≥ 50 ml/min.
  • Fertile women must present a negative pregnancy test and use contraceptives during and 3 months after treatment. An IUD without hormone is considered a safe contraceptive.
  • Written and orally informed consent prior to any study related procedure.

Exclusion Criteria:

  • Local recurrence or counter-lateral breast cancer without other dissemination.
  • Pregnant or breastfeeding women.
  • Clinical symptoms of CNS metastases, incl. meningeal carcinomatosis.
  • Malabsorption syndrome or other disease affecting the gastrointestinal function. Resection of the ventriculus or the small intestine, which can affect absorption of oral vinorelbine.
  • Dysphagia or other conditions preventing the patient from swallowing tablets.
  • Mental or social conditions preventing treatment or follow-up.
  • Serious concurrent medical condition, such as:

    • AMI within 12 months or unstable angina.
    • Heart incompensation NYHA III or IV or uncontrolled hypertension (systolic > 150 mm/hg and/or diastolic >100 mm/hg).
    • Serious arrythmia requiring medication, excl. atrial fibrillation and paroxystic supraventricular tachycardia.
    • Active infection, uncontrolled diabetes or hypercalcemia.
  • Other concurrent experimental treatment.
  • Concurrent antihormonal treatment of metastatic breast cancer.
  • Known neuropathia ≥ grade 2.
  • Other previous malignant disease within the past 5 years excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  • Previous treatment with vinca alkaloid.
  • Previous serious allergic or unexpected reactions to trastuzumab treatment.

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 identifier (NCT number): NCT01242449

Dept. of Oncology, Aalborg Sygehus
Aalborg, Denmark, 9000
Dept. of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
Department of Oncology, Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Vejle Hospital
Principal Investigator: Troels Bechmann, MD Department of Oncology, Vejle Hospital
Study Chair: Erik H Jakobsen, MD Department of Oncology, Vejle Hospital

Responsible Party: Vejle Hospital Identifier: NCT01242449     History of Changes
Other Study ID Numbers: 2010-021618-42
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: March 2015

Keywords provided by Vejle Hospital:
Breast cancer
HER2 positive

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