Breast Neoplasm, Metastasis
Conditions
Keywords
Breast Neoplasm Metastasis, Receptor,HER-2, Eribulin, Furans, ketones, Antimitotic agent
Brief summary
Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage. The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.
Interventions
DRUGEribulin
Sponsors
MedSIR
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic breast cancer HER2 negative, stage IIIb/IV * Previous history of early disease (stage I-IIIb), surgically resected and treated with standard chemotherapy for at least 12 weeks at which included a taxane or ixabepilone * Patients must have progressed in the 36 months after treatment with taxanes or ixabepilone. * Age ≥ 18 years * Given written informed consent * Index of Eastern Cooperative Oncology Group (ECOG) of 0 or 1 * Patients must have recovered from toxicities related with previous treatment (CTC ≥ 1) * Measurable or evaluable disease (RECIST 1.1) * Adequate bone marrow function * Adequate hepatic function * Adequate renal function * Life expectancy ≥ 3 months
Exclusion criteria
* Breast cancer patients initially diagnosed with local disease advanced or metastatic disease. * Patients who have previously received cytotoxic therapy Hormone therapy permitted if the patients have interrupted it at least two weeks before the start of the study treatment. * Major surgery or significant traumatic injury during the 4 weeks prior to study treatment or patients who may require major surgery during the assay. * Brain metastases or leptomeningeal uncontrolled. * Serious medical condition and / or not properly controlled (unstable angina, lung function severe impaired, uncontrolled diabetes, active serious infection,liver disease, HIV seropositivity, active bleeding diathesis) * Other malignancies in the last three years, except: cervical carcinoma in situ, basal cell carcinoma or squamous cell skin carcinoma,that have been properly treated * Patients who are pregnant or breastfeeding, or adults with reproductive capacity wich are not using effective contraception. * Patients receiving chronic treatment with systemic corticosteroids or other immunosuppressive drugs (except corticosteroids with a daily dose equivalent to prednisone ≤ 20mg on a stable dose regimen one minimum of 4 weeks prior to study entry. Topical and inhaled corticosteroids are allowed * Active alcoholism or drugs addiction documented. * Prior history of noncompliance with medical regimens * Patients who do not want or can not comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Through study completion, up to 27 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | Through study completion, up to 27 months | Duration of response |
| Clinical Benefit Rate | Through study completion, up to 27 months | — |
| Progression Free Survival | Through study completion, up to 27 months | — |
Countries
Spain
Participant flow
Recruitment details
A total of 53 taxane-resistant patients with HER2- locally advanced or MBC treated with Eribulin as first-line chemotherapy were enrolled between 2013 and 2015 in a total of 14 sites.
Pre-assignment details
Patients must comply: MBC HER2- stage IIIb/IV. Previous early disease (I-IIIb) diagnosis, surgically resected and treated with chemotherapy 12w (must include taxane or ixabepilone). Must have progressed 48m after. Age ≥ 18 years. ECOG performance status 0 or 1. Measurable or evaluable disease (RECIST 1.1). Adequate bone marrow, hepatic and renal function. Life expectancy ≥ 3m.
Participants by arm
| Arm | Count |
|---|---|
| Monotherapy Treatment With Eribulin Eribulin Dosage: 1.4 mg/m2. Route of administration: IV bolus. Schedule of cycle: D1 and D8 every 21 days. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
Baseline characteristics
| Characteristic | Monotherapy Treatment With Eribulin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age, Continuous | 47 years |
| Region of Enrollment Portugal | 4 participants |
| Region of Enrollment Spain | 49 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 53 |
| other Total, other adverse events | 39 / 53 |
| serious Total, serious adverse events | 11 / 53 |
Outcome results
Primary
Time to Progression
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Time frame: Through study completion, up to 27 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Monotherapy Treatment With Eribulin | Time to Progression | 4.1 months |
Secondary
Clinical Benefit Rate
Time frame: Through study completion, up to 27 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monotherapy Treatment With Eribulin | Clinical Benefit Rate | 14 Participants |
Secondary
Duration of Response
Duration of response
Time frame: Through study completion, up to 27 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Monotherapy Treatment With Eribulin | Duration of Response | 4.5 months |
Secondary
Progression Free Survival
Time frame: Through study completion, up to 27 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Monotherapy Treatment With Eribulin | Progression Free Survival | 4.1 Months |