GIM22-ERICA is a clinical trial investigating the efficacy of two different strategies in HER2 negative MBC treatment. The study will include MBC patients with histologically documented HER2 negative disease, who have progressed to one prior regimen for metastatic disease and are eligible for a second-line chemotherapy with either eribulin or capecitabine. This study design should answer to different questions: * What is the correct placement of Eribulin in the context of a long term treatment strategy? * Is an early use of Eribulin the best approach for MBC pts treatment? * May early use of Eribulin impact on subsequent treatment outcomes? The correlated biomarkers analysis, evaluating angiogenic, epithelial and mesenchymal markers should confirm the results observed in preclinical studies ad support the clinical findings. Liquid biopsies and ctDNA evaluation could help to monitor the course of the disease and to identify novel biomarkers of drug resistance.
Patients who are considered eligible for the study treatment, will be randomly allocated within the two study arms. ARM A: * Second line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days * third line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days ARM B: * Second line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days * Third line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days Study treatment will be continued until disease progression, death, unacceptable toxicity, Investigator's decision or patient refusal of further treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
The dose of Eribulin as the ready to use solution is 1.23 mg/m2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle. The amount of Eribulin required (calculated above) will be withdrawn from the appropriate number of vials into a syringe. This may be injected directly as an IV bolus over 2-5 minutes or diluted in up to 100 ml 0.9% sodium chloride (NaCl) for IV infusion over 2-5 minutes. The dose of Eribulin may be reduced or discontinued during any cycle in accordance with the toxicity modifications described in this chapter. Toxicities will be managed by treatment interruption and dose reduction. Once the dose has been reduced, it cannot be increased at a later date
Capecitabine use in breast cancer is registered as monotherapy in advanced breast cancer after failure of a taxane- and anthracycline-containing chemotherapy or for patients for whom an anthracycline is contraindicated. Capecitabine is available in tablets of 150 and 500 mg. The recommended dose as a single agent is 1,250 mg/m2 b.i.d. (twice daily) for 14 days repeated on day 22. The tablets should be swallowed with water within 30 minutes after a meal. Caution is recommended in patients with ischemic heart disease or coronary artery disease and/or in therapy with sorivudine and analogs, coumarins, and phenytoin.
Fondazione Poliambulanza, Istituto Ospedaliero
Brescia, Italy
A.R.N.A.S. Garibaldi - P.O. Nesima
Catania, Italy
A.O. Pugliese-Ciaccio
Catanzaro, Italy
A.O. S. Croce e Carle
Cuneo, Italy
Ospedale Civile degli Infermi
Faenza, Italy
Ospedale Fabrino Spaziani
Frosinone, Italy
Ospedale Policlinico San Martino
Genova, Italy
A.O. Ospedale Papardo
Messina, Italy
AORN dei Colli - Ospedale Monaldi
Napoli, Italy
Azienda Ospedaliero Universitaria Federico II
Napoli, Italy
...and 15 more locations
Total Progression Free Survival (PFS-T)
Total-progression-free survival (PFS-T) is defined as the time elapsed between randomization and the first event among the following: * the date of progression after the second treatment on study -whichever the second treatment will be according to intention-to-treat (eventual departures from treatments planned in the protocol will be described) * the date of death if death occurs before second progression Patients who are alive and who do not fall into any of the above categories at the end of the study will be censored on the date of the last information on vital status.
Time frame: 62 months
Overall Survival from the date of randomization
This is defined as the time elapsed from the first day of 2nd line therapy and death
Time frame: 62 months
Health-related Quality of Life (QoL)
Assessment will be performed by using EORTC QoL questionnaires (QlQ C30 and specific EORTC QlQ BR23)
Time frame: At screening and then every 8 weeks (including at the time of disease progression/s)
Disease Control Rate
Disease Control Rate (DCR: proportion of patients obtaining complete response or partial response or stable disease \>= 6 months): * in second line; * In third line; * In second and/or third line.
Time frame: 62 months
Post Progression Survival (PPS)
This is defined as the time elapsed from disease progression after 3rd line of therapy and death;
Time frame: 62 months
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