NCT01730833CompletedPhase 2
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
Phase II Prospective Open Label Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with human epidermal growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies, such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 16 Nov 2012
- Start date
- 25 Jul 2013
- Primary completion date
- 12 Jan 2021
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01730833
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From 25 Jul 2013 to the primary completion date, 12 Jan 2021
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior breast cancer or other invasive malignancy treated within 5 years
- Cumulative dose of doxorubicin or equivalent of \> 360 mg/m\^2 during prior adjuvant therapy
Other illness
- Known active hepatitis B or C
- Known active human immunodeficiency virus (HIV)
- Another malignancy excluding basal cell skin cancer
Lab values
- LVEF \< 50% during previous trastuzumab therapy
Other
- Pregnancy
- Neuropathy \> grade 1
- Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/principal investigator (PI)
- Central nervous system metastases
- Pregnant women
- Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Who the study is looking for
- Patients must be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Tumor positive or negative for expression of hormone receptors (\< 1% or \> 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing
- For patients with LABC, no prior therapy is allowed
- For patients with MBC, prior adjuvant chemotherapy and trastuzumab more than or equal to 12 months prior to enrollment are allowed
- No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
- Left ventricular ejection fraction (LVEF) \>= 50% (determined by echocardiogram or multigated acquisition scan) within 42 days of treatment
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Hemoglobin \>= 9 g/dl
- Leukocytes \>= 3.0 x 10\^9/L
- Absolute neutrophil count \>= 1.5 x 10\^9/L
- Platelets \>= 100 x 10\^9/L
- Total bilirubin =\< 1.3 mg/dl (institutional upper limit of normal)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 x institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance \> 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault formula)
- All radiology studies (study requiring staging) must be performed within 35 days prior to the start of therapy
- No serious medical conditions such as myocardial infarction within 6 months prior to entry, congestive heart failure, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, psychiatric illness, or any other medical conditions that might be aggravated by treatment or limit compliance
- Currently, no active second malignancy other than non-melanoma skin cancer; note: patients are not considered to have a "current active" malignancy if they have completed anti-cancer therapy and are considered by their physicians to have a less than 30% chance of relapse
- All patients must have the ability to understand and the willingness to sign an informed consent
- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential
- No prior therapies (except for anti-estrogen therapy) are allowed for the treatment of the newly diagnosed metastatic breast cancer; patients are allowed to have had prior chemotherapy for breast cancer in the adjuvant setting for at least 12 months prior to enrollment into this study; patients with a prior diagnosis of malignancy treated \>= 5 years ago are eligible, provided that they have not received prior nab-paclitaxel as part of their prior treatment regimen, and that they meet all eligibility criteria
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope Antelope Valley Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| City of Hope- South Pasadena Cancer Center Coordinator of this site? Confirm its status | South Pasadena | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.