Oral Vinorelbine in Combination With Trastuzumab for Metastatic Breast Cancer

NCT01242449 | Completed Phase 2 DMC

• 1 other identifier: 2010-021618-42
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Metastatic; HER2 positive; vinorelbine

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  CT scan and MUGA scan

  Every 9 weeks. Up to 2 years

Secondary Outcomes (2)

• Progression free survival

  Every 9 weeks from date of first treatment until progression or death. Up to 2 years

• Overall Survival

  From date of inclusion until date of death. Up to 2 years.

Interventions

Trastuzumab DRUG

Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks

Vinorelbine DRUG

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.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (3)

Dept. of Oncology, Aalborg Sygehus

Aalborg, 9000, Denmark

Location

Dept. of Oncology, Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Troels Bechmann, MD

  Department of Oncology, Vejle Hospital

  PRINCIPAL INVESTIGATOR

• Erik H Jakobsen, MD

  Department of Oncology, Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-03

Locations

DK (3)