Metastatic Breast CancerPhase 2NCT05833919
Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer Patients
A Phase 2 study testing Eribulin Mesylate and Capecitabine in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 25 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Eribulin Mesylate and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 25 sitesItaly
- Study dates
- 30 Jul 2018to Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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);
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- 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).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
Fondazione Poliambulanza, Istituto Ospedaliero
Brescia, 25124
A.R.N.A.S. Garibaldi - P.O. Nesima
Catania, 95122
A.O. Pugliese-Ciaccio
Catanzaro, 88100
A.O. S. Croce e Carle
Cuneo, 12100
Ospedale Civile degli Infermi
Faenza, 48018
Ospedale Fabrino Spaziani
Frosinone, 03100
Ospedale Policlinico San Martino
Genova, 16132
A.O. Ospedale Papardo
Messina, 98158
AORN dei Colli - Ospedale Monaldi
Naples, 80131
Azienda Ospedaliero Universitaria Federico II
Naples, 80131
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Naples, 80131
Università degli studi della Campania L. Vanvitelli
Naples, 80131
P.O. Santa Maria delle Grazie - ASL Napoli 2 Nord
Pozzuoli, 80078
P.O. San Paolo - ASL Roma 4
Roma, 00053
Università Campus Biomedico
Roma, 00128
Policlinico Universitario Tor Vergata
Roma, 00133
IFO - Istituto Nazionale Tumori Regina Elena - U.O.C. Oncologia Medica 1
Roma, 00144
IFO - Istituto Nazionale Tumori Regina Elena - U.O.C. Oncologia Medica 2
Roma, 00144
Ospedale Sandro Pertini - ASL Roma 2
Roma, 00157
Fondazione Policlinico A. Gemelli
Roma, 00168
Policlinico Universitario A. Gemelli
Roma, 00168
Presidio Cassia Sant'Andrea - ASL Roma 1
Roma, 00189
ASST Lariana - Ospedale Sant'Anna
San Fermo della Battaglia, 22020
ASUFC P.O. "Santa Maria della Misericordia"
Udine, 33100
ASST Sette Laghi - Ospedale Di Circolo e Fondazione Macchi
Varese, 21100
About this study
Official title: Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer (MBC) Patients: a Randomized Phase II Study - ERICA Trial
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:
Read more
- 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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Eribulin Mesylate, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin MesylateDrug
Also called Eribulin
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
CapecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Second line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days followed by third line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days. Receives: Drug: Eribulin Mesylate; Drug: Capecitabine |
| ARM B | Experimental | Second line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days; followed by third line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days. Receives: Drug: Eribulin Mesylate; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 62 months
Secondary outcomes (4)
Overall Survival from the date of randomization
This is defined as the time elapsed from the first day of 2nd line therapy and death
Measured: 62 months
Health-related Quality of Life (QoL)
Assessment will be performed by using EORTC QoL questionnaires (QlQ C30 and specific EORTC QlQ BR23)
Measured: 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.
Measured: 62 months
Post Progression Survival (PPS)
This is defined as the time elapsed from disease progression after 3rd line of therapy and death;
Measured: 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start30 Jul 2018
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario R D'Andrea, MD, Study chair, UOSD Oncologia, Presidio Ospedaliero San Paolo, Civitavecchia, Rome, ItalyMichelino De Laurentiis, MD, Principal investigator, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833919
- Sponsor's protocol ID
- GIM22-ERICA
- Status last verified
- Apr 2023
- First submitted
- 1 Feb 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer (MBC) Patients: a Randomized Phase II Study - ERICA Trial
- ClinicalTrials.gov ID
- NCT05833919
- Acronym / sponsor ID
- GIM22-ERICA
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: Eribulin Mesylate, Drug: CapecitabineSecond line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days followed by third line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days. |
| ARM B | Experimental | Drug: Eribulin Mesylate, Drug: CapecitabineSecond line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days; followed by third line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin MesylateAlso: EribulinThe 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 | Drug | ARM A, ARM B |
| CapecitabineCapecitabine 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. | Drug | ARM A, ARM B |
Primary outcome
Total Progression Free Survival (PFS-T)
Time frame: 62 months
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.
4 secondary outcomes
Overall Survival from the date of randomization
Time frame: 62 months
Health-related Quality of Life (QoL)
Time frame: At screening and then every 8 weeks (including at the time of disease progression/s)
Disease Control Rate
Time frame: 62 months
Post Progression Survival (PPS)
Time frame: 62 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario R D'Andrea, MD study chair
UOSD Oncologia, Presidio Ospedaliero San Paolo, Civitavecchia, Rome, Italy
Michelino De Laurentiis, MD principal investigator
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin Mesylate and Capecitabine in people with Metastatic Breast Cancer, run by Consorzio Oncotech at 25 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Progression Free Survival (PFS-T) (time frame: 62 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.