A trial using blood tests to detect cancer cells after standard treatment to trigger additional treatment in early stage triple negative breast cancer patients
- Conditions
- Breast cancerCancer
- Registration Number
- ISRCTN12569958
- Lead Sponsor
- Institute of Cancer Research
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36423745/ (added 04/01/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 208
Current inclusion criteria as of 31/10/2019:
1. Signed Informed Consent Form for Registration
2. Male or female patients ages 16 years or older
3. ECOG performance status 0, 1 or 2
4. Histologically proven primary triple negative breast cancer as defined as oestrogen receptor (ER) negative, progesterone receptor (PgR) negative (if available, otherwise PgR unknown), (as defined by Allred score 0/8 or 2/8 or stain in <1% of cancer cells) and HER2 negative (immunohistochemistry 0/1+ or negative by in situ hybridization) as determined by local laboratory
5. Availability of tissue from two archival tumour tissue samples (either from diagnostic biopsy, and/or primary surgery). If only one tumour sample is available, the site should inform the ICR-CTSU who will discuss eligibility with the Chief Investigator (or designated TMG member). Patients who have tumours previously sequenced outside the c-TRAK TN trial must provide one archival tumour tissue sample and the report that confirms the mutations detected
6. Patients with moderate or high-risk early-stage triple-negative breast cancer according to the following risk of relapse criteria:
6.1. Neoadjuvant chemotherapy (no adjuvant chemotherapy planned):
6.1.1. High-risk criteria - Residual microscopic or macroscopic invasive cancer in the axillary nodes after chemotherapy
6.1.2. Moderate risk criteria - Residual invasive cancer in the breast, and axillary lymph node negative after chemotherapy
6.2. Adjuvant chemotherapy:
6.2.1. High-risk criteria - Tumour size >50mm and node positive OR =4 nodes positive regardless of primary tumour size
6.2.2. Moderate risk criteria - Tumour size >20mm AND/OR involved axillary macroscopic lymph node
6.3 Both neoadjuvant and adjuvant chemotherapy:
Patients who have received both neoadjuvant chemotherapy and further adjuvant chemotherapy must fulfil only the adjuvant chemotherapy risk criteria to be eligible. They can fulfil the criteria on either clinical staging prior to neoadjuvant chemotherapy or pathological staging at surgery
7. Patients must be registered according to the following criteria for timing of registration:
7.1. Neoadjuvant chemotherapy (no adjuvant chemotherapy planned):
Patients must be registered within 6 weeks of surgery. Patients may be registered before or during radiotherapy and should be registered as early as possible
7.2. Adjuvant chemotherapy (no neoadjuvant chemotherapy received):
Patients must be registered before, or on the day of, the 3rd cycle of adjuvant chemotherapy and should be registered as early as possible
7.3. Both neoadjuvant and adjuvant chemotherapy
Patients must be registered within 6 weeks of surgery. Patients may be registered before or during radiotherapy. Patients must register before starting capecitabine
8. Consent to provide research blood samples
9. Patients with bilateral tumours can be included if both are triple negative and if two archival tissues samples can be provided per tumour.
10. Patients must have had surgery achieving clear margins (as per local guidelines).
11. Female and male patients
Current exclusion criteria as of 26/10/2018:
1. Any concurrent or planned treatment for the current diagnosis of breast cancer other than surgery, locoregional adjuvant radiotherapy, standard adjuvant chemotherapy, or a bisphosphonate/denosumab
2. Prior treatment with a PDL1, PD1, or other immunomodulatory therapy
3. Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ
4. Patients previously entered into a therapeutic trial during or after neoadjuvant chemotherapy where experimental therapy is continued post-surgery
5. Treatment with an unlicensed or investigational product within 4 weeks of trial entry
6. Active autoimmune disease requiring systemic therapy in the last two years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of such systemic treatment
7. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
8. Known history of active TB (Tuberculosis Bacillus)
9. Known history of Human Immunodeficiency Virus (HIV)
10. Known active Hepatitis B or Hepatitis C
11. Known history of, or any evidence of active, non-infectious pneumonitis
12. Active infection requiring systemic therapy
13. Previous solid organ transplantation or allogenic stem cell transplantation
14. Females who are pregnant or breastfeeding
15. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent
16. A pathological complete response (pCR) to neoadjuvant chemotherapy (added 31/10/2019)
Previous exclusion criteria as of 03/05/2018:
1. Any concurrent or planned treatment for the current diagnosis of breast cancer other than surgery, locoregional adjuvant radiotherapy, standard adjuvant chemotherapy, or a bisphosphonate/denosumab
2. Prior treatment with a PDL1, PD1, or other immunomodulatory therapy
3. Prior diagnosis of cancer including prior diagnosis of breast cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ
4. Patients previously entered into a therapeutic trial during or after neoadjuvant chemotherapy where experimental therapy is continued post-surgery
5. Treatment with an unlicensed or investigational product within 4 weeks of trial entry
6. Active autoimmune disease requiring systemic therapy in the last two years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of such systemic treatment
7. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy withi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method