Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy

Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy - Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy (CYBORG-002)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012452

Enrollment

Registered

2013-12-02

Start date

2013-11-26

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-Positive Metastatic Breast Cancer

Interventions

Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 60-75 mg/m2 every

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients who are 18 years or older with breast cancer which is confirmed to be invasive breast cancer by histological examination 2. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods 3. ECOG performance status(PS) is 0, 1 or 2 4. Patients with measurable lesions by Response Evaluation Criteria In Solid Tumors (RECIST) 5. The number of prior trastuzumab therapy is within 3 regimen. 6. Major organ function is maintained. 7. Left-ventricular ejection fraction (LVEF) is at least 50% at baseline. 8. Signed informed consent was obtained from patient.

Exclusion criteria

Exclusion criteria: 1. Patients who have an active infection or high fever with suspicious infection. 2. Patients who have a history of cardiac disease, including known symptomatic decreases in LVEF to less than 50% absolute value during prior trastuzumab therapy or congestive heart failure. 3. Patients with pulmonary fibrosis or interstitial pneumonia that is clear from the chest X-ray 4. Patients with previous exposure to a cumulative dose of doxorubicin of more than 360 mg/m2 5. Patients with a decline in LVEF to less than 50% during or after former trastuzumab treatment 6. Patients suspected of being pregnant or pregnant women 7. Patients with another malignancy within the last 5 years 8. Patients with uncontrollable brain metastases 9. Patients who were considered by the primary care physician to be inappropriate as subjects of this trial

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Progression free survival Clinical benefit rate Overall survival Safety	—

Countries

Japan

Contacts

Public ContactMutsumi Ishi

Tokyo Dental College Ichikawa General Hospital Department of Pharmacy

mishii@tdc.ac.jp047-322-0151

Outcome results

None listed

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