a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 neg. metastatic breast cancer

a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 negative metastatic breast cancer (MBC) - protocol GOIM 21002

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000393-35-IT

Enrollment

Registered

2012-03-30

Start date

2012-02-01

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic breast cancer (MBC) Her-2 negative as first line treatment MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: abraxane Product Code: NA Pharmaceutical Form: Solution for infusion INN or Proposed INN: NA CAS Number: 33069-62-4 Current Sponsor code: NA Other descriptive name: NA Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. documented diagnosis of Her-2 neg o triple neg metastatic breast cancer, 2. age > o = 18 years, 3. no prior chemiotherapy for metastatic disease, 4. previous hormonal therapy as adjuvant or as I line treatment is allowed, 5. previous therapy with taxanes is allowed as adjuvant or neoadjuvant treatment if completed from at least 6 months, 6. previous treatment with anthracyclines is not mandatory, 7. PS 0-1, 8. consens informed Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 94

Exclusion criteria

Exclusion criteria: 1. documented brain metastases, 2. sensory neuropathy more than grade 1, 3. positive pregnancy test

Design outcomes

Primary

Measure	Time frame
Main Objective: the efficacy of combination in terms of responce rate; the progression free survival;Secondary Objective: overall survival; tolerability and safety;Primary end point(s): 1. the efficacy of combination in terms of response rate, 2. the progression free survival;Timepoint(s) of evaluation of this end point: 2 years	—

Secondary

Measure	Time frame
Secondary end point(s): 1. overall survival, 2. tolerability and safety;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Italy

Contacts

Public Contactcentro dati GOIM (data manager)

gruppo oncologico italia meridionale

colucci@goim.it080/5555448

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026