Phase II trial evaluating gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer: GAMBA trial

Phase II trial evaluating gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer: GAMBA trial - GAMBA (Gemzar + Abraxane for Metastatic Breast cAncer) trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005145

Enrollment

Registered

2011-03-01

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

HER2-negative metastatic breast cancer

Interventions

gemcitabine + nanoparticle albumin-bound paclitaxel

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed invasive breast cancer 2) ECOG performance status 0 or 1 3) HER2-negative metastatic breast cancer 4) At least one measurable lesion 5) Previously untreated with taxanes (Eligible if taxanes are used in neo-adjuvant or adjuvant setting and completed more than 24 weeks before registration.) 6) Previously untreated with gemcitabine 7) Previously treated with no more than one chemotherapy regimen for metastatic disease

Exclusion criteria

Exclusion criteria: 1) Double cancer 2) Pulmonary fibrosis 3) Symptomatic brain metastasis 4) Uncontrolled pleural effusion, pericardial effusion, and ascites 5) HBsAg-positive

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Safety	—

Countries

Japan

Contacts

Public ContactToshimi Takano

Toranomon Hospital Department of Medical Oncology

takano@toranomon.gr.jp03-3588-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026