Halifax Health – Center for Oncology
Clinical Trials Available for Recruitment
For further information contact the Clinical Trials Department at 386.425.4213
Breast – Agendia FLEX Registry- Breast Cancer
MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
- Adult males and female patients with: Stage I, II or III who receive MammaPrint, with or without BluePrint testing.
- New Primary Lesion
- Excluded if: Metastatic Disease, Recurrent Disease, Stage 0 Disease
Breast – Protocol ID: SWOG S1418
A Randomized, Phase III Trial to Evaluate the Efficacy of and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy. Change in protocol name PVD 7-30-19.
- Male or Female at least 18 years old
- Triple Negative (ER-, PR-, HER2 Negative * (Patients with Weakly Positive ER- and/or PR- cancers and/or HER2 equivocal status cancers by ASCO CAP guidelines also eligible. Not received or planning Adj. anti-HER2 or Endocrine Therapies after Neo-adj chemo.
- Weakly ER or PR + disease: defined as ER and/or PR <5% by ICH, are eligible.
- Must have residual invasive breast cancer after neoadjuvant chemotherapy (1cm or greater in size and /or have positive lymph nodes ypN1mi,ypN1,ypN2,ypn3 on path exam)
- Must complete adjuvant therapy prior to starting Pembrolizumab. Must be reg. within 35 days after completion of therapy.
- Allows pts with HER2 borderline results who haven’t received adjuvant Anti-HER2 therapy.
- No Metastatic disease.
- Completion of neoadjuvant chemo followed by surgery. Neoadj. If not completed for any reason are considered high risk and eligible for the trial if they have residual disease.
- Enroll up to 24 weeks post-op adjuvant Chemo after completion of surgery at MD discretion.
- Be registered within 90 days of surgery and free margins with no treatment or 270 days after adjuvant therapy. If RT is needed Pts. After random. And receive MK-3475 concurrently.
- Performance status equal to or less than 2
- No prior therapy with anti-PD-L1, Anti-PD-1 and anti-CTLA4.
Breast – ALLIANCE A011401
Randomized Phase III Trial Evaluating The Role of Weight Loss in Adjuvant treatment of Overweight and Obese Women with Early Breast Cancer.
- BMI > 27
- Histologically Confirmed Invasive Breast Cancer within last 12 months, No evidence T4
- Bilateral Breast Ca is allowed if synchronous or within 3 months of each other
- HER2 Negative- (Can be ER and/or PR Positive or Neg.) TNM Staging:
– If ER and /or PR+ then Staging T0-3N1-3or T3N0
– If ER and/or – then Staging T2 or T3 N0, T0-3N1-3
- No Hx Breast Ca in last 5 years
- Complete CXR or a Bone Scan, between Dx and Registration.
- All Adjuvant and Neoadjuvant Chemo and surgery completed 21 days prior to Registration
Colon – Protocol: A021502
Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair.
- Must be ≥ 18
- Performance Status < 2
- Histologically proven Stage III
- Adenocarcinoma. (any T), N1-2M0: includes N1c
- DNA Mismatch Repair(MMR) Status: Presence of deficient (d) DNA mismatch repair (dMMR)
- Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel
- Tumors can only be located in the Colon no rectal involvement. Noted where and included with distal or proximal to splenic flexure.
- Must not have had previous treatment for Colon Cancer except 1 cycle mFOLOX6.
- No active autoimmune disease
- No other planned Investigational therapy or chemo or radiation while on study.
- No daily trmt with corticosteroids (>10 mg daily prednisone) within 7 days prior to registration.
- 10 week window from surgery extended from registration to randomization for initiation of treatment
Lung – ALLIANCE A151216 (ALCHEMIST)
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
- Males and Females are eligible
- Suspected Dx of Resectable NSCLC
- Suspected Clinical Stage IIIA, II (IIA /IIB) or Lg IB(Defined >4cm)
- ECOG Performance Staus 0-1
- Age >18
- Haven’t received any Neoadjuvant therapy
- No advanced or Metastatic ca within 5 years or Secondary primary Lung Ca within 2 years
- No prior Treatment with agents targeting EGFR Mutation, ALK, PD!/PD-L1/CTLA-4
- No Pregnant Pts
- No patients with Recurrence of Lung Cancer after prior Resection
Consents available at site https://clinicaltrials.gov/ct2/show/NCT02194738?term=A151216&rank=1
Lung – Protocol ID: ALLIANCE A081105 (ALCHEMIST – Treatment)
New Protocol Name as of 12/28/2018: Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
- Previously Registered into A151216 with the result of Lung Ca harboring EGFR Exon 19 Deletion or L858R Mutation via:
- Assessment done by protocol Central lab
- Local CLIA Lab and result available, pt registered in above trial.
- Completely Resected II or IIIA or IB(4cm or greater) Non Squamous NCCLC with Negative Margins
- Complete recovery from surgery must be at least 28 days and no more than 90 days if no Adjuvant chemo or 240, if Adjuvant Chemo. 300 if Adjuvant and Radiation
- Age 18 or greater
- ECOG performance Status 0-1
- No Hx Cornea Abnormalities
- Requires Initial Lab values
Lung – Protocol ID: ECOG-ACRIN E4512 (ALCHEMIST – Treatment)
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.
- Age 18 or greater
- ECOG performance Status 0-1
- Previously Registered into A151216 and Positive for the ALK Gene by Vysis Break Point FISH Assay
- Baseline Chest CT performed within 6 months prior to randomization to ensure no disease
- Must have had complete resection of their IB (>4cm). II, or non-squamous IIIA (N3 disease not allowed) and have Negative Margins. N3 disease is not allowed.
- No prior Tx with Crizotinib or another ALK Inhibitor.
- No Ongoing Grade 2 cardiac dysrhythmias, Uncontrolled A-Fib any Grade.
- Complete recovery from surgery must be at least 28 days and no more than 90 days if no Adjuvant chemo or 240 if Adjuvant Chemo. 300 if Adjuvant and Radiation.
Myelodysplastic Syndromes & Acute Myeloid Leukemia – Protocol ID: Connect® MDS and AML AZA-MDS-006
The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry.
- Newly diagnosed, primary or secondary MDS or AML or Idiopathic Cytopenia of Undetermined Significance (ICUS)
- MDS / ICUS patients must be at least 18 years old
- AML patients must be at least 55 years old
- No active treatment (disease modifying) agents for ICUS or MDS prior to enrollment
- AML patients may have begun active, disease modifying treatment within 14 days of informed consent date
- Supportive care growth factors, transfusions, etc. are allowed prior to enrollment
- Confirmed diagnosis made up to 60 days prior to the date of informed consent.
- All supporting diagnostic reports go through central eligibility review.