Can a second round of pertuzumab help fight advanced breast cancer?
NCT ID NCT02514681
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 3 trial tested whether giving pertuzumab again, along with trastuzumab and chemotherapy, could help people with HER2-positive advanced breast cancer who had already received pertuzumab before. The study enrolled 226 participants and compared retreatment to standard trastuzumab and chemotherapy alone. The main goal was to see if retreatment could delay cancer progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pertuzumab (Perjeta) combined with trastuzumab (Herceptin) and chemotherapy drugs
- What this could lead to
- If successful, this could offer a new treatment option for people with HER2-positive advanced breast cancer who have already been treated with pertuzumab, potentially delaying disease progression.
- What could go wrong
- This is a completed phase 3 trial, but retreatment may not provide significant benefit over standard therapy. Side effects from chemotherapy and targeted drugs remain a risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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226 people
The number who actually took part.
- Started
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Aug 2015
- Finished
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Aug 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically confirmed invasive breast cancer 2. A confirmed HER2-positive status assessed by means of immunohistochemical analysis (with 3+ indicating positive status) and/or in situ hybridization (with an amplification ratio \> 2.0 indicating positive) by each institute 3. History of pertuzumab and trastuzumab-containing chemotherapy for locally advanced and metastatic breast cancer(2 or 3 regimen as previous chemotherapy regimen for locally advanced or metastatic breast cancer). The latest regimen before enrollment dose not include pertuzumab. 4. Patients have measurable and/or non-measurable disease according to RECIST ver1.1. 5. Female patients and aged ≥ 20 years. 6. Left Ventricular Ejection Fraction (LVEF) \> 50% at baseline (within 28 days before enrollment) as determined by either ECHO or MUGA 7. Eastern Cooperative Oncology Group performance status of 0,1 or 2. 8. Life expectancy of patients is expected at least 3 months. 9. Signed and written informed consent (approved by the Institutional Review Board or Independent Ethics Committee) is obtained before any study procedure. Exclusion Criteria: 1. History of chemotherapy \> 4 regimen for locally advance or metastatic disease except for cancer chemotherapeutic agent-free treatment regimen (eg, hormonal therapy alone, combination with hormonal therapy and trastuzumab and anti-HER2 therapy alone). 2. Persistent Grade \>3 non-hematologic toxicity according to NCI-CTCAE v4.0-JCOG resulting from previous therapy at the time of enrollment. 3. Symptomatic or uncontrolled central nervous system metastases. 4. Multiple malignancies without history of breast cancer(within 10 years if invasive breast cancer and within 5 years if malignancies except invasive breast cancer) 5. History of exposure to the following cumulative doses of anthracyclines: * doxorubicin or liposomal doxorubicin \> 360 mg/m2 * epirubicin \> 720 mg/m2 * mitoxantrone \> 100 mg/m2 * If more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin. 6. Current uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg) or unstable angina. 7. History of CHF of any New York Heart Association criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia). 8. History of myocardial infarction within 6 months of enrollment. 9. Dyspnea at rest due to complications of advanced malignancy. 10. Inadequate organ function, as determined by the following laboratory results, within 28 days before enrollment: * Absolute neutrophil count \< 1,500/mm3 * Platelet count \< 100,000/mm3 * Hemoglobin \< 8.0 g/dL * Total bilirubin \> 2.0 mg/dL, unless the patient has documented Gilbert's syndrome * Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 100IU /L with the following exception (If considered that the liver dysfunction due to liver metastases \> 200 IU/L, or 100 \< , ≤200 IU/L with serum albumin \< 2.5 g/dL) * Serum creatinine value \> 2.0 mg/dL or 177 μmol/L 11. Current severe uncontrolled systemic disease(eg. Clinically significant cardiovascular, pulmonary and metabolic disease\*, disorder of wound healing, ulcer and fracture) \*If gemcitabine is planned to be selected as a combination chemotherapeutic agent,patients who has symptomatic interstitial pneumonia or pulmonary fibrosis on chest X-ray should be excluded. 12. Uncontrolled malignancy-associated hypercalcemia syndrome under bisphosphonates or denosumab treatment. 13. Radiation related grade \>2 adverse event within 14 days before enrollment. 14. Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of need for major surgery during the course of study treatment. 15. Pregnant woman or positive pregnancy test. 16. Nursing woman 17. History of receiving any investigational treatment within 28 days before enrollment. 18. Current known and active infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus. 19. Receipt of intravenous antibiotics for infection within 14 days before enrollment. 20. Current chronic daily treatment (continuous for \> 3 months) with corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. 21. Known hypersensitivity to pertuzumab or trastuzumab without infusion reaction related to these drugs 22. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aichi Cancer Center
Chikusa-ku, Aichi-ken, 4648681, Japan
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Japan Breast Cancer Research Group
Chuo-ku, Nihonbashi, Koami-cho, Tokyo, 1030016, Japan
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Kumamoto University Hospital
Kumamoto, Kumamoto, 8608556, Japan
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