NCT04281641 Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
| NCT ID | NCT04281641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2020-04-21 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2020-04-21 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy. 2. Primary tumor greater than (\>) 2 cm in diameter. 3. Age ≥ 18 years and \< 70 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1. 5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55% 6. Availability of tumor tissue specimen after surgery. 7. Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay. 8. Histologically proven diagnosis of breast cancer. 9. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH). 10. Had hormonal receptors (ER and PgR) assessed. 11. Signed informed consent. 12. Able to comply with the protocol. Exclusion Criteria: 1. Metastatic disease (Stage IV) or bilateral breast cancer. 2. Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer. 3. Prior breast or non-breast malignancy within 5 years prior to study entry. 4. Inadequate bone marrow, renal, or liver function 5. History or evidence of cardiovascular condition 6. Severe, uncontrolled systemic disease 7. Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications. 8. Pregnancy or breast-feeding women. 9. Participants who received any investigational treatment within 4 weeks of study start. 10. Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus. 11. Current chronic daily treatment with corticosteroids (dose \>10 mg methylprednisolone or equivalent \[excluding inhaled steroids\]). 12. Known hypersensitivity to any of the study drugs or excipients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04281641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04281641 currently recruiting?
Yes, NCT04281641 is actively recruiting participants. Contact the research team at wujiong1122@vip.sina.com for enrollment information.
Where is the NCT04281641 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04281641 clinical trial?
NCT04281641 is sponsored by Fudan University. The trial plans to enroll 94 participants.
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