Paclitaxel + Bevacizumab versus doxorubicina liposomiale non pegilata (Myocet), cyclophosfamide e Bevacizumab as the first line treatment in HER-2 negative metastatic breast cancer. Multicenter randomized Study of phase II

Paclitaxel + Bevacizumab versus doxorubicina liposomiale non pegilata (Myocet), cyclophosfamide e Bevacizumab as the first line treatment in HER-2 negative metastatic breast cancer. Multicenter randomized Study of phase II - Protocol GOIM 21001

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006176-39-IT

Enrollment

Registered

2012-06-12

Start date

2012-07-12

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 HER2 negative 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

Pharmaceutical Form: Injection CAS Number: 33069-62-4 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 90- Pharmaceutical Form: Solution for injecti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: breast cancer HEr2 negative istologically confirmed 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Bone metastasis as unic site of desease Previous chemotherapy for metastatic desease or concomitant therapy with hormonal agents or byotherapy Sintomatic cerebral metastasis Hipertension non controlled Psychic desease Cardiac desease, ictus,transient ischemic attack, TIA SNC desease Ipersensibility to bevacizumab or to agents of protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: to value the activity of chemotherapic combinations in terms of objective response rate;Secondary Objective: To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival;Primary end point(s): to value the activity of chemotherapic combinations in terms of objective response rate;Timepoint(s) of evaluation of this end point: With an accettable tass of response non inferior to 62%, with a level of significativity of 5% and with a potency of 90%, 21 objective responses will be needed in the first 34 patients to consider active the combination of braccio B therapy. into second phase 36 patients will be needed.	—

Measure

Time frame

Main Objective: to value the activity of chemotherapic combinations in terms of objective response rate;Secondary Objective: To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival;Primary end point(s): to value the activity of chemotherapic combinations in terms of objective response rate;Timepoint(s) of evaluation of this end point: With an accettable tass of response non inferior to 62%, with a level of significativity of 5% and with a potency of 90%, 21 objective responses will be needed in the first 34 patients to consider active the combination of braccio B therapy. into second phase 36 patients will be needed.

—

Secondary

Measure	Time frame
Secondary end point(s): To value the quality of life, the tossicity of treatment (in particular the cardiotossity), the time to progression and the overall survival;Timepoint(s) of evaluation of this end point: the time of response, the time to progression and the overall survival will be calculated with Kaplan-Meier's method	—

Countries

Italy

Contacts

Public ContactCentro dati GOIM (Data Manager)

Gruppo Oncologico Italia Meridionale

colucci@goim.it0805555448

Outcome results

None listed

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