Know Cancer

or
forgot password

Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer, HER2 Positive, First or Second Line Therapy, Failure or Contraindication of Trastuzumab Therapy

Thank you

Trial Information

Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab


The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive
metastatic breast cancer. This study combines this therapy with the additional antimitotic
mode of function by vinorelbine.


Key

Inclusion Criteria:



- Written informed consent

- Able to comply with the protocol

- ECOG performance status 0-1

- Adequate contraception

- Confirmed Her2/neu-positive, adenocarcinoma of the breast

- At least one measurable lesion according to RECIST 1.1 criteria

- First or second chemotherapy after diagnosis of metastasis

- Lapatinib treatment indicated (adjuvant trastuzumab treatment <12 months ago or
progressive disease with trastuzumab treatment)

- No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection
fraction) at study start at least 55%

- Adequate hepatic and renal function value

- Adequate hematologic function values

Exclusion Criteria:

- Pregnant or lactating women

- Concurrent participation in another clinical trial. Prior participation is allowed if
the last study medication was administered more than 4 weeks prior to randomization

- Asymptomatic with regards to tumor illness

- Previous treatment with lapatinib, capecitabine or vinorelbine

- Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to randomization, or anticipation of the need for major surgery during the
course of the study

- Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina
pectoris or arrhythmia

- History of vascular or cardiovascular disease within the past 6 months

- All illnesses that result in malabsorption of oral medication or inability to take
oral medication

- Concurrent treatment with anti-viral drugs based on sorivudine or with
aminoglycosides

- Concurrent treatment with any drug interfering with study medication, especially,
those that induce CYP3A

- Concurrent treatment with allopurinol

- Other malignancies (except for basal cell carcinoma of the skin and cervical
carcinoma in situ); patient can be included in the study if no recurrent disease has
been observed for at least 5 years

- Concurrent illnesses or other circumstances that could interfere with trial
participation, efficacy or safety of the patient

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine

Outcome Description:

Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Ulrike Soeling, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jordanstr. 6, 34117 , Kassel, Germany

Authority:

Germany: Ethics Commission

Study ID:

0907-002

NCT ID:

NCT01238029

Start Date:

October 2010

Completion Date:

December 2011

Related Keywords:

  • Metastatic Breast Cancer
  • HER2 Positive
  • First or Second Line Therapy
  • Failure or Contraindication of Trastuzumab Therapy
  • Dose finding study
  • Combination
  • Breast Neoplasms

Name

Location