A clinical trial is a research study designed to evaluate the safety and effectiveness of new cancer treatment options. This type of research improves the treatment of cancer. As a result of these trials, cancer survival rates have increased, quality of life has improved and side effects have decreased for many patients.

Our Current Trials

BREAST

BRCA Positive
NSABP B-55 –Phase III Study to Assess the Efficacy and Safety of Olaparib vs Placebo as Adjuvant Treatment in Patients with Germline BRCA ½ Mutations and High Risk HER2 Negative Primary Breast Cancer who have completed Definitive Lovcal Treatment and Neoadjuvant or Adjuvant Therapy

Adjuvant ERPR+ & HER2Negative
PALLAS – A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy vs Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HER+)/Human Epidermal Growth Factor receptor 2 (HER2)-Negative early breast cancer.

Adjuvant/Triple Negative
NRG-BR003:
A Randomized, Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High Risk Node-Negative Triple Negative Invasive Breast Cancer

Metastatic – HER2 Positive
Spectrum SPI-POZ-201 – A Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic Breast Cancer Who Have Received Prior HER2 Regimens for MBC.

ENDOMETRIAL

Millenium C31004 – Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128 + MLN1117 (a PI3Ka Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women with Advanced, Recurrent, or Persistent Endometrial Cancer.

LUNG - NON-SMALL CELL

Screening Trial

A151216: Adjuvant Lung Cancer Enrichment Marker Identification an Sequencing Trial (ALCHEMIST)

(Genetic Testing for Patients with Resectable or Resected Lung Cancer) Prior to enrollment in A081105 or E4512

EGFR Mutant Patients
A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor (EGFR) Mutant NSCLC

ALK Fusion Protein Patients
E4512: A Phase III Double-Blind Trial of Surgically Resected Early Stage NSCLC: Crizotinib vs Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase Fusion Protein

SMALL CELL LUNG – MAINTENANCE THERAPY

Abbvie M16-298 – A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First Line Platinum Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)

LUNG LIMITED SMALL CELL

CALGB 30610 – Phase 3 Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide

OTHER SOLID TUMORS

KYOWA 0761-014: Open-Label, Multicenter Phase 1/ 2 Study of Mogamulizumab in Combination with Nivolumab in Subjects with Locally Advanced or Metastatic Solid Tumors

 

OVARIAN

Platinum Resistant-at least 3 regimens and DO NOT carry the BRCA mutation
Astra Zeneca Concerto: Single arm, open label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrenet platinum resistant epithelial ovarian cancer, including fallopian tube and/or primary peritoneal cancer who DO NOT carry a deleterious or suspected deleterious germline BRCA mutation.

Platinum Sensitive
NRG-GY004 – A Phase III Study Comparing Single Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in women with Recurrent Platinum-Sensitve Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Platinum Resistant
NRG-GY005 – A Randomized, Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer (COCOS)

RECTAL

CTSU N1048 – Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation vs Postoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection withTotal Mesorectal Excision

BLOOD DRAWS

NaNonics: Blood draw to indentify a set of cell signals that consistently indicate presence, regression, or progression of solid tumor cancer in patients by measuring the serum levels of multiple cell signals

Toray: Pilot Study: Analysis of Serum miRNA from Women Referred for Breast Biopsy with Abnormal Breast Imaging Classified at BI-RADS 4 or 5

How Can I Participate in a Clinical Trial?

We have a number of trials available and will offer one to you if appropriate. Keep in mind that most clinical trials have strict eligibility criteria to protect patients and provide the best chance for success.  Age,  gender, cancer type and prior treatments may be included in  the selection criteria.  That means not all patients are eligible for a clinical trial.

What are the phases of a Clinical Trial?

Phase I trials assess the safety of a new medication or treatment.

Phase II trials also assess the safety of a new medication or treatment, but often measure the effectiveness of those treatments as well.

Phase III trials measure the effectiveness and safety of a new medication or treatment compared to the existing best practice.

What if I Get a Placebo?

Cancer patients participating in clinical trials will always receive a treatment that is equivalent to, or possibly better than, the standard treatment.  Placebo trials are never used when there is a potentially effective therapy available. Your doctor and research team can explain the details of placebo-controlled trials to you during your office visits.

Will My Clinical Trial Work?

There’s no guarantee that your clinical trial will work. However, before every clinical trial starts, the designers of the trial must present evidence that convinces the Food and Drug Administration (FDA) that the trial is a logical treatment option.

Can I Quit My Clinical Trial?

Participation in clinical trials is completely voluntary. Every participant in a clinical trial signs an informed consent form that outlines the trial’s potential benefits and risks. During the trial, the research team will monitor you closely and help manage any side effects you may experience. You can decide to stop participating in the trial at any time.