Eribulin as 1st Line Treatment in Elderly Patients With Advanced 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.|
|ClinicalTrials.gov Identifier: NCT02404506|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : March 1, 2019
Breast cancer is the most frequent malignancy in women, world-wide the leading cause of cancer mortality. One of the strongest risk factors for developing breast cancer is age, with a prevalence approaching 7% in women >70 years; more than 40% of breast cancer patients are older than 65 years. Although the survival rate has increased in the last years, about one third of patients will relapse with distant metastases. Treatment for patients with metastatic breast cancer is palliative, therefore maintaining or improving quality of life.
The use of taxanes and anthracyclines as first line chemotherapy regimen for metastatic breast cancer is widely accepted. Both taxanes and anthracyclines have considerable side effects, especially in elderly patients.
Eribulin, a synthetic analogue of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai, acts as an inhibitor of microtubule dynamics. It is registered as palliative chemotherapy in advanced breast cancer after anthracyclines and taxanes. Studies with eribulin treatment have shown similar efficacy compared to anthracyclines and taxanes, but less toxicity. Those studies showed that often the dose of eribulin had to be reduced during treatment due to toxicity without compromising the efficacy of the treatment.
The main objective of the trial is to explore the efficacy of a reduced starting dose of eribulin as first-line treatment in elderly metastatic breast cancer patients. The secondary objective of the trial is to investigate the safety of eribulin in those patients.
Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and day 8 until progressive disease.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Adenocarcinoma||Drug: Eribulin mesilate||Phase 2|
Due to a rising number of elderly patients, fit for chemotherapy, investigating a well-tolerated and effective first line treatment is warranted. In this specific population often there are contra-indications for the use of standard first line drugs like anthracyclines and taxanes due to comorbidities (e.g. cardiac impairment or Peripheral neuropathy). Response rates in first line treatment with taxanes and anthracyclines usually do not exceed 30%. Eribulin has shown a response rate of 29% and a clinical benefit rate (corresponding to the investigators primary endpoint) of 52% in first line, so the investigators expect similar efficacy, but less toxicity.
Optimal dose, schedule and tolerability of this drug in the first line setting are unknown in the elderly population. No information on dose modifications in this population is available. Based on the data of eribulin in the first line with higher efficacy in those patients with dose reductions, the SAKK 25/14 trial investigates the reduced starting-dose of eribulin of 1.1mg/m2 for this vulnerable population of elderly patients. Growth factors to maintain a certain dose level of eribulin are not recommended, respecting the international guidelines.
SAKK has a tradition in conducting trials in the elderly population, such as SAKK 25/99 in metastatic breast cancer, SAKK 38/08 in aggressive B-cell-Lymphoma, SAKK 41/10 in metastatic colorectal cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Eribulin as 1st Line Treatment in Elderly Patients (≥ 70 Years) With Advanced Breast Cancer: a Multicenter Phase II Trial|
|Actual Study Start Date :||August 17, 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||October 2023|
|Experimental: Arm: Eribulin mesilate||
Drug: Eribulin mesilate
Eribulin mesiylate 1.1mg/m2 d1, 8 every 3 weeks until Progressive disease PD
Other Name: Halaven
- Disease Control (DC) [ Time Frame: 24 weeks ]A patient has DC, if she has complete response (CR) or partial response (PR) at any time point during treatment, or if she has stable disease (SD) for at least 24 weeks (according to RECIST v1.1).
- Time to treatment failure (TTF) [ Time Frame: at treatment discontinuation (at the latest 5 years after registration) ]time from registration until treatment discontinuation due to any reason or the occurrence of a second tumor. Patients still on treatment will be censored at the date of their last eribulin administration
- Objective response (OR) [ Time Frame: at treatment discontinuation (at the latest 5 years after registration) ]
A patient is defined as having OR, if she has CR or PR according to RECIST v1.1 at any time point during treatment.
For the primary analysis, all responses (CR, PR) will be considered, including unconfirmed responses. In a sensitivity analysis, only those responses for which a confirmatory measurement at least 4 weeks later is available will be counted as CR or PR
- Time to progression (TTP) [ Time Frame: at time of progression, death or treatment discontinuation (at the latest 5 years after registration) ]
TTP is defined as time from registration until documented progression according to RECIST v1.1 or death due to tumor.
Patients not experiencing an event and patients starting a new anticancer therapy in the absence of an event will be censored at the date of their last available tumor assessment showing non-progression.
- Overall survival (OS) [ Time Frame: at time of death (at the latest 5 years after registration) ]OS is defined as time from registration until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.
- Adverse events (AEs) [ Time Frame: until 30 days after last dose of treatment and resolution of all related AEs thereafter (at the latest 5 years after registration) ]AEs will be assessed according to NCI CTCAE v4.0.
- Patient reported neuropathy (PRO Form) and characterization of patients based on cancer-specific geriatric assessment (C-SGA) [ Time Frame: at the first follow-up visit (at the latest 5 years after registration) ]
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): NCT02404506
|Aarau, Switzerland, CH-5001|
|Baden, Switzerland, 5404|
|Basel, Switzerland, 4031|
|Praxis für ambulante Tumortherapie|
|Basel, Switzerland, CH-4052|
|Istituto Oncologico della Svizzera Italiana|
|Bellinzona, Switzerland, 6500|
|Klinik Engeried / Oncocare|
|Bern, Switzerland, 3012|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2501|
|Chur, Switzerland, 7000|
|Kantonsspital Frauenfeld / Brustzentrum Thurgau|
|Frauenfeld, Switzerland, 8501|
|HFR Fribourg - Hôpital cantonal|
|Fribourg, Switzerland, 1708|
|Clinique de Genolier|
|Genolier, Switzerland, CH-1272|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Clinica Sant'Anna - Oncologia Varini & Calderoni & Christinat|
|Lugano, Switzerland, 6900|
|Luzerne, Switzerland, CH-6000|
|Onkologie Zentrum Spital Männedorf|
|Männedorf, Switzerland, 8708|
|Olten, Switzerland, 4600|
|Rundum Onkologie am Bahnhofpark|
|Sargans, Switzerland, 7320|
|Onkologiezentrum Bürgerspital Solothurn|
|Solothurn, Switzerland, CH-4500|
|Onkologiepraxis Dr. med. Isabella Schönenberger|
|St. Gallen, Switzerland, 9000|
|St. Gallen, Switzerland, 9006|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Thun, Switzerland, 3600|
|Winterthur, Switzerland, 8401|
|Onkozentrum - Klinik im Park|
|Zurich, Switzerland, 8002|
|Brust-Zentrum AG Zürich|
|Zürich, Switzerland, 8005|
|Study Chair:||Ursula Hasler-Strub, MD||Cantonal Hospital of St. Gallen|