Official Title
An Observational Phase II Trial of Targeted Next Generation Sequencing Analysis for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Patients With HER2 Positive Breast Cancer
Brief Title
Targeted Next Generation Sequencing for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Breast Cancer
Protocol ID
NCT03728829
Lead Sponsor
Hebei Medical University Fourth Hospital
Brief Summary
To explore the genetic background of patients with HER2 positive breast cancer that
benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically
actionable mutations that associated with trastuzumab resistance or drug efficacy, we
designed this Observational phase II trial. The primary endpoint is genetic profile of
HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy.
Secondary endpoints included pathological complete response (pCR) rate and safety.
Detailed Description
Currently, patients with stage II-III breast cancer still accounts for a large population
in China, and neoadjuvant therapy is considered the standard treatment for them. The
pathological complete response (pCR) rate takes for an indicator for regimens efficacy,
and the achievement of pCR after neoadjuvant chemotherapy is associated with favorable
outcomes including disease-free survival and overall survival.
HER2+ breast cancer represents an invasive and poor prognosis subtype, and the efficacy
of neoadjuvant therapy for these patients has been greatly augmented by the addition of
trastuzumab. However, more than 50% of HER2+ breast cancer patients treated with
trastuzumab combined neoadjuvant chemotherapy cannot achieve pCR, even experience primary
drug resistance and rapid disease progression. Therefore, to explore the genomic features
of the population that benefited from trastuzumab combined with chemotherapy is of great
significance for personalized treatment of HER2+ breast cancer, aiming to avoid
overtreatment and identify clinically actionable mutations for future therapy
instructions.
Enrollment Count
100 participants
Eligibility Criteria
Inclusion Criteria:
- women aged 18-70 years old at the time of diagnosis of primary breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- Stage III breast cancer according to the 7th Edition of Cancer staging Manual of
American Joint Committee on Cancer (AJCC)
- full assessment of ER, PR and HER2 status of primary tumor in accordance with the
American Society of Clinical Oncology (ASCO) guidelines
- pathological diagnosis and all courses of treatment confirmed
Exclusion Criteria:
- any known metastatic disease, by physical exam or by imaging studies such as
computed tomography (CT)/magnetic resonance imaging (MRI), at the time of study
entry
- any previous exposure to chemotherapy, radiotherapy, or endocrine therapy
- left ventricular ejection fraction (LVEF) < 55% by Echocardiogram (ECHO) or
multigated acquisition scan (MUGA) or significant clinical symptoms or signs of
heart failure
- major organ dysfunction, inclusive of bone marrow, renal, liver and hepatic
function, that would prohibit patients from receiving standard chemotherapy
Filters
Observational
Prospective
UNKNOWN
ADULT
OLDER_ADULT