Clinical Trials Updates | Breast and Liver Cancer Awareness Edition

 

Advancing Cancer Care Through Research


Welcome to the Clinical Trials Connect — your quarterly update on actively enrolling clinical trials at the Barbara Ann Karmanos Cancer Institute. This month's newsletter highlights select breast and liver cancer studies, offering your patients access to innovative treatments and research-driven care. We also encourage you to explore the full list of available trials using the Karmanos Clinical Trials App, a convenient tool to search by cancer type, eligibility, therapy, and more. For more detailed information, visit our Clinical Trials page.



Refer with ease. Call our referring physician line: 1-877-KARMANOS (1-877-527-6266) or

refer a patient online.

 

ACTIVELY RECRUITING TRIALS

 

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care.

A Phase I Dose-Escalation and Metabolomics Study of Metformin Combined with Chemotherapy and/or Immunotherapy in Solid Malignancies



Phase: Phase I

Principal Investigator: Wasif Saif, M.D., MBBS

Karmanos Trial ID: 2024-050

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

Therapies: Biological Therapy

Drug: Metformin

Cancer Categories: Breast, Gastrointestinal, Gynecologic, Lung, and Skin


Eligibility Criteria

  • Any advanced solid tumor with measurable disease per RECIST 1.1
  • Patient must be a candidate for chemotherapy and/or immunotherapy
  • Not currently taking metformin


Refer a Patient

BREAST CANCER TRIALS


A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Durvalumab Compared with Investigator's Choice of Chemotherapy (Paclitaxel, Nab-Paclitaxel or Gemcitabine + Carboplatin) in Combination with Pembrolizumab in Patients with PD-L1 positive Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer (TROPION-Breast05)


Phase: Phase III

Cancer Category: Breast

Principal Investigator: Jailan Elayoubi, M.D.

Karmanos Trial ID: 2024-049

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

Therapies: Chemotherapy


Eligibility Criteria

  • Locally recurrent inoperable or metastatic triple-negative breast cancer
  • PD-L1 positive (CPS ≥ 10) per PD-L1 (22C3) assay
  • No prior chemotherapy for metastatic or locally recurrent inoperable breast cancer
  • Eligible for paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin


Refer a Patient

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer



Phase: Phase II

Principal Investigator: Brian Yeh, M.D.

Karmanos Trial ID: 2021-056

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute at McLaren Bay Region
  • Karmanos Cancer Institute at McLaren Central Michigan
  • Karmanos Cancer Institute at McLaren Flint
  • Karmanos Cancer Institute at McLaren Greater Lansing
  • Karmanos Cancer Institute at McLaren Lapeer Region

Therapies: Proton Therapy, Radiation Therapy


Eligibility Criteria

  • ER+ invasive ductal carcinoma and/or ductal carcinoma in situ
  • Lumpectomy performed, with documented negative surgical margins by 0.2 cm or more
  • Stage 0, I, II (Tis, T1, or T2 N0 M0); must be pN0
  • Must be >= 50 years of age


Refer a Patient

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer



Phase: Phase III

Cancer Category: Breast

Principal Investigator: Jailan Elayoubi, M.D.

Karmanos Trial ID: S2206

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
  • Karmanos Cancer Institute at McLaren Greater Lansing

Therapies: Chemotherapy, Immunotherapy


Eligibility Criteria

  • ER+/PR+/HER2- breast cancer, clinical stages II or III
  • MammaPrint High Risk 2 result (testing provided during screening)
  • No prior treatments; must be a candidate for doxorubicin, paclitaxel, and durvalumab therapy
  • ECOG 0-2


Refer a Patient

LIVER CANCER TRIALS


A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE (EMERALD-Y90)


Phase: Phase II

Principal Investigator: Najeeb Al Hallak, M.D.

Karmanos Trial ID: 2024-021

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

Therapies: Immunotherapy, Radiation Therapy


Eligibility Criteria

  • Confirmed hepatocellular carcinoma by imaging with no evidence of extrahepatic disease
  • Disease is not amenable to curative surgery, ablation, or transplantation
  • Disease is amenable to complete treatment with TARE in one session, with no more than 70% of liver radiated
  • Child-Pugh score class A


Refer a Patient

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma


Phase: Phase I/II

Principal Investigator: Najeeb Al Hallak, M.D.

Karmanos Trial ID: 2022-069

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

Therapies: Biological Therapy, Immunotherapy


Eligibility Criteria

  • Locally advanced or metastatic and unresectable hepatocellular carcinoma
  • Child-Pugh class A or B7
  • Cohort A: Objective progression on up to 3 prior lines of systemic therapy
  • Cohort B: Objective progression following at least 2 cycles of first-line anti-PD-1/PDL1 monotherapy or combination therapy
  • Cohort C: Naïve to systemic treatment for locally advanced or metastatic, and unresectable HCC


Refer a Patient

TheraBionic P1 Device for Patients with Advanced Hepatocellular Carcinoma (HCC) who Fail First and Second Line Therapy


Phase: Phase IV

Principal Investigator: Anthony Shields, M.D., Ph.D.

Karmanos Trial ID: 2024-074

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit
  • Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

Drugs: TheraBionic P1 Device


Eligibility Criteria

  • Advanced hepatocellular carcinoma
  • Failed at least two lines of therapy or are no longer eligible for any line of standard therapy
  • Patient must be ≥ 22 years old


Refer a Patient

INTERVENTIONAL TRIALS


Increasing Knowledge and Interest in Cancer Clinical Trials


Applicable Disease Sites: Breast; Colon; Liver; Other Digestive Organ; Small Intestine; Stomach

Principal Investigator: Hayley Thompson

Karmanos Trial ID: 2019-137

Age Group: Adults

Locations Available:

  • Karmanos Cancer Institute - Detroit


Eligibility Criteria

  • All adults aged 21 and older
  • No cancer diagnosis required


Refer a Patient

 

PHASE I CLINICAL TRIALS


The Eisenberg Center for Translational Therapeutics houses the Phase I Clinical Trials Program at the Karmanos Cancer Center in Detroit. The program is the only one of its kind in Michigan.


Members of Karmanos' Phase I Clinical Trials Multidisciplinary Team conduct clinical research studies with new investigational cancer drugs.

 

SHARE WITH YOUR PATIENTS


The Barbara Ann Karmanos Cancer Institute is partnering with Wayne State University (WSU) School of Medicine to help adult cancer survivors meet exercise and strength training goals in classes tailored to evaluate and promote the benefits of exercise on the well-being of survivors in a free 12-week program.


Contact the CAPABLE team at 313-578-4246 or email CAPABLE@wayne.edu to refer a patient or for more information.

 

BEHIND THE REFERRALS

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