Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Recruiting · NCT04281641 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
TCHP
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
- Primary tumor greater than (\>) 2 cm in diameter.
- Age ≥ 18 years and \< 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
- Availability of tumor tissue specimen after surgery.
- Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
- Histologically proven diagnosis of breast cancer.
- 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).
- Had hormonal receptors (ER and PgR) assessed.
- Signed informed consent.
- Able to comply with the protocol.
Exclusion criteria
- Metastatic disease (Stage IV) or bilateral breast cancer.
- Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
- Prior breast or non-breast malignancy within 5 years prior to study entry.
- Inadequate bone marrow, renal, or liver function
- History or evidence of cardiovascular condition
- Severe, uncontrolled systemic disease
- Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
- Pregnancy or breast-feeding women.
- Participants who received any investigational treatment within 4 weeks of study start.
- Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
- Current chronic daily treatment with corticosteroids (dose \>10 mg methylprednisolone or equivalent \[excluding inhaled steroids\]).
- Known hypersensitivity to any of the study drugs or excipients
Where it is running
1 location listed.
- Shanghai Cancer Center, Fudan University - Shanghai, Shanghai Municipality, China