Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Evaluation of Degree of Conversion of HER2 Receptor Between Primary Breast Cancer and Metastasis

Summary: This is a Prospective Clinical Trial without drugs, to determine the HER2 status in the metastasis of patients with primary breast cancer HER2. 236 patients have been recruited and 32 Sites have been taking part in this Clinical Trial.
  Primary Objective:
  -  To determine prospectively the probability of stage HER2 conversion between the different subtypes of primary breast cancer (luminal, triple negative and HER2) and their metastasis.
  Secondary Objective:
  - To determine the probability of changes in ER and PR between different subtypes of primary breast cancer and their metastasis.
  -  Analyze the variability in the measurement of HER2, ER and PR between local laboratories and central laboratory.
  -  Evaluate HER2 conversion rate compared to previously received treatment.
  -  Evaluate whether the location of metastasis biopsied relates to the probability of conversion of HER2.
  -  Compare the disease-free survival (DFS) and survival post relapse (SPR) of patients with or without conversion of HER2 and ER/PR.
  -  Compare the response rate (RR) and time to progression (TTP) for subsequent anti-tumor treatment of patients with or without conversion of HER2.
  -  Analyze the extent to which discrepancies in the HER2 receptor status, ER and PR between the primary tumor and metastasis alter the clinical management of patients.
  -  Analyze the feasibility of performing biopsies.
  -  Evaluate whether the HER2 status conversion really is associated with activation of intracellular markers of the HER2 signaling pathway: pMAPK, PERK, pAKT, PTEN, PIGF-1R in paired samples (primary tumor and their metastasis).
  -  Check if there is any change in the molecular subtypes (luminal, triple negative, HER2) between primary tumors and metastases in patients with HER2 conversion.


Eligibility: Inclusion Criteria:
  -  Patients who have given their written informed consent to participate in the study.
  -  Women over 18 years.
  -  Breast cancer locally recurrent or metastatic at first relapse or after successive progressions.
  -  Patient has to have available a sample of the primary tumor in paraffin.
  -  Patients who are planning for the next 6 weeks, the biopsy (fine needle aspiration / drainage of fluid cavities, open biopsy, core biopsy) of locally recurrent or metastatic lesion [local relapse in the chest wall, nodal , cutaneous or subcutaneous metastases, peripheral lymph nodes and other soft tissues accessible, bone metastases, visceral metastases (lung, liver, brain, etc..) or pleural effusion / ascites / pericardial / cerebrospinal] according to clinical practice center.
  Exclusion Criteria:
  -  Patients with cognitive impairment that might impede a proper understanding of the written informed consent, according to medical criteria.
  -  ipsilateral breast local relapses or contralateral breast away.
  -  Patients diagnosed with a second neoplasm, with the exception of cervical carcinoma in situ and non-melanoma skin carcinoma treated properly.

Relevance to patient case: definitely relevant