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Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer

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About this study

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.

Condition
HER2-positive Breast Cancer
Tested
TCHP
Sponsor
Fudan University

Who can join

Age
18 to 70 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Study condition: HER2-positive Breast Cancer
  • 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 12

  • 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

1 site, 1 recruiting

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.