Trial Title:
Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer Patients
NCT ID:
NCT05833919
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
HER 2 negative MBC patients, who have progressed to a first line chemotherapy for
metastatic disease and meet all the inclusion criteria, will be considered eligible for
study enrollment. Patients will be randomly allocated using a 1:1 allocation centralized
method into the two study arms: ARM A or ARM B.
Randomization will be performed with a minimization procedure that will account for the
following parameters as strata:
- center;
- ECOG Performance Status (0-1 vs 2);
- previous use of CDK inhibitor (yes vs no);
- previous use of bevacizumab (yes vs no);
- triple negative breast cancer (yes vs no).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Eribulin Mesylate
Description:
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amount of Eribulin required (calculated above) will be withdrawn from the appropriate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
Arm group label:
ARM A
Arm group label:
ARM B
Other name:
Eribulin
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
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.
Arm group label:
ARM A
Arm group label:
ARM B
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent (both for clinical and blood biomarker study)
- Histological diagnosis of HER2 negative MBC
- Females ≥ 18 years
- Measurable disease (according RECIST criteria version 1.1)
- Prior Anthracyclines and Taxanes in either (neo-) adjuvant or metastatic setting,
unless the patient was not suitable for one of these treatments
- 1 prior cytotoxic regimen for advanced or MBC (not including adjuvant or
neo-adjuvant therapy). Patients with no prior cytotoxic regimens for advanced or
metastatic disease will only be allowed if they relapsed during or within 6 months
of (neo-) adjuvant cytotoxic therapy that included anathracyclines and/or taxanes
(see prior criteria);
- Prior hormonotherapy and Cyclines inhibitors are allowed, so as indicated in the
international guidelines for the management of hormone positive breast cancer (ER
and/or PR positive);
- ECOG Performance Status ≤ 2
- Absence of angina or heart failure or infarction within 12 months from inclusion
- Adequate bone marrow and organ function as follows (haemoglobin ≥9.0 g/dl; absolute
neutrophil count ≥ 1.5x103/mm3; plateled count ≥ 100x103/mm3; bilirubin levels ≤ 1.5
times Upper Limits of Normal
- biliary stenting is allowed to resolve obstruction - Serum Transaminase level ≤ 2.5
times ULN; serum creatinine ≤ 1.5 times ULN;
- Life expectancy of at least 12 weeks;
- If women of childbearing potential (WOCBP) age: effective contraceptive measures
must be used during the study treatment period and up to 3 months after the last
dose of study drug.
Exclusion Criteria:
- Unability to give informed consent
- Absence of measurable disease
- Concurrent active malignancies (except of in situ carcinoma of the cervix and
inactive non-melanoma skin cancer)
- Current active infection;
- Serious pre-existing medical conditions or serious concomitant diseases;
- systemic disorders that would compromise the safety of the patient or her ability to
complete the study, at the discretion of the investigator (for example, unstable
angina pectoris, or a clinically significant history of cardiac disease or
uncontrolled diabetes mellitus);
- Known immunodeficiency virus infection;
- Pregnant or breastfeeding women
- Unable to undergo medical test for geographical, social or psychological reason;
- Active or symptomatic brain metastases;
- Known complete Dihydropyrimidine dehydrogenase (DPD) deficiency (phenotype and/or
genotype testing, according to applicable national guidelines, prior to the
initiation of treatment with Capecitabine is recommended)
- Recent or concomitant treatment with brivudine (there must be at least a 4-week
waiting period between end of treatment with brivudine and start of capecitabine
therapy).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Poliambulanza, Istituto Ospedaliero
Address:
City:
Brescia
Zip:
25124
Country:
Italy
Facility:
Name:
A.R.N.A.S. Garibaldi - P.O. Nesima
Address:
City:
Catania
Zip:
95122
Country:
Italy
Facility:
Name:
A.O. Pugliese-Ciaccio
Address:
City:
Catanzaro
Zip:
88100
Country:
Italy
Facility:
Name:
A.O. S. Croce e Carle
Address:
City:
Cuneo
Zip:
12100
Country:
Italy
Facility:
Name:
Ospedale Civile degli Infermi
Address:
City:
Faenza
Zip:
48018
Country:
Italy
Facility:
Name:
Ospedale Fabrino Spaziani
Address:
City:
Frosinone
Zip:
03100
Country:
Italy
Facility:
Name:
Ospedale Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Facility:
Name:
A.O. Ospedale Papardo
Address:
City:
Messina
Zip:
98158
Country:
Italy
Facility:
Name:
AORN dei Colli - Ospedale Monaldi
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Azienda Ospedaliero Universitaria Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Università degli studi della Campania L. Vanvitelli
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
P.O. Santa Maria delle Grazie - ASL Napoli 2 Nord
Address:
City:
Pozzuoli
Zip:
80078
Country:
Italy
Facility:
Name:
P.O. San Paolo - ASL Roma 4
Address:
City:
Roma
Zip:
00053
Country:
Italy
Facility:
Name:
Università Campus Biomedico
Address:
City:
Roma
Zip:
00128
Country:
Italy
Facility:
Name:
Policlinico Universitario Tor Vergata
Address:
City:
Roma
Zip:
00133
Country:
Italy
Facility:
Name:
IFO - Istituto Nazionale Tumori Regina Elena - U.O.C. Oncologia Medica 1
Address:
City:
Roma
Zip:
00144
Country:
Italy
Facility:
Name:
IFO - Istituto Nazionale Tumori Regina Elena - U.O.C. Oncologia Medica 2
Address:
City:
Roma
Zip:
00144
Country:
Italy
Facility:
Name:
Ospedale Sandro Pertini - ASL Roma 2
Address:
City:
Roma
Zip:
00157
Country:
Italy
Facility:
Name:
Fondazione Policlinico A. Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Facility:
Name:
Policlinico Universitario A. Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Facility:
Name:
Presidio Cassia Sant'Andrea - ASL Roma 1
Address:
City:
Roma
Zip:
00189
Country:
Italy
Facility:
Name:
ASST Lariana - Ospedale Sant'Anna
Address:
City:
San Fermo Della Battaglia
Zip:
22020
Country:
Italy
Facility:
Name:
ASUFC P.O. "Santa Maria della Misericordia"
Address:
City:
Udine
Zip:
33100
Country:
Italy
Facility:
Name:
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Address:
City:
Varese
Zip:
21100
Country:
Italy
Start date:
July 30, 2018
Completion date:
July 2023
Lead sponsor:
Agency:
Consorzio Oncotech
Agency class:
Other
Source:
Consorzio Oncotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833919
