Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study.

Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting.

Eribulin

Yuichiro Kikawa, MD

Takeshi Kotake, MD

This is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. The purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in Japan. The total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. All patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the Japanese Breast Cancer Society Clinical Practice Guideline of Breast Cancer and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Investigators at the investigational sites will enter patient data into an electronic data capture (EDC) system up to the third chemotherapy in the study. The end of the study is defined as the time the last patient completes observational period. Patients will primarily be assessed by overall survival (OS) of the first line chemotherapy.

Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer

Prospective Observational Study to Explore the Efficacy of Eribulin as 1st-line or 2nd-line Chemotherapy in Patients With HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer

Kyoto Breast Cancer Research Network

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Adenocarcinoma

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Androgens

Hormone Antagonists

EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles).

EPI-7386

160 mg administered orally once daily, with or without food

Enzalutamide

Androgen Deprivation Therapy (ADT)

Pedro Barata, MD, MSc

Christopher Wee, MD

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.

EPI-7386 is an investigational drug that works by blocking the androgen receptor at a different site compared to the approved androgen receptor blockers. This may increase the effectiveness of this drug and increase the effectiveness of approved androgen receptor blockers when taken together. EPI-7386 is a new drug; therefore, its effectiveness and safety in prostate cancer patients must be studied before it is approved by the Food and Drug Administration. EPI-7386 is experimental because it is not currently approved by the Food and Drug Administration (FDA). Enzalutamide is approved by the FDA for patients whose prostate cancers has spread after receiving treatment. The hypothesis is that adding EPI-7386 to standard hormone therapy will be more effective in treating cancer compared to usual treatment, with the long term goal of discovering more about hormone therapy as a treatment for cancer.

Phase 2, single-arm study composed of 2 stages: in the first stage, 13 subjects diagnosed with mHSPC will be enrolled and treated with EPI-7386 in combination with enzalutamide. If there are 8 or less subjects with a biochemical response at 6 months, then the trial will be suspended. Otherwise, 22 additional subjects will be enrolled and treated.

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Phase 2 Trial Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Individual participant data that underlie or influence the results observed from the study.

Defined as prostate-specific antigen (PSA) undetectable (\<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.

Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed

Plasma area under the concentration-time curve from time zero to 24 hours (AUC0-24)

Observed predose plasma concentration during multiple dosing (Ctrough)

Time it takes to reach maximum concentration

Apparent terminal elimination half-life (t½), whenever feasible to calculate

Apparent volume of distribution at steady state after extravascular administration (Vss/F)

Apparent clearance after extravascular administration.

Treatment-emergent adverse events (TEAEs) (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)

The presenece of abnormalities in clinical laboratory parameters will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment.

The presence of abnormalities in vital sign measurements will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to the study treatment.

The presence of abnormalities in ECGs will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to the study treatment.

Changes in ECOG performance status. The ECOG performance status relies on a scale with scores ranging from 0-5, where 0 indicates the highest function, and 5 indicates lowest function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer	NCT02551263	Breast Cancer	Eribulin	20 Years - 75 Years	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Eribulin Treatment as 1st-line or 2nd-line Chemotherapy for HER2-negative Hormone-resistant Inoperable or Recurrent Metastatic Breast Cancer	NCT02551263	Breast Cancer	Eribulin	20 Years - 75 Years	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer	NCT06312670	Metastatic Horm... Prostate Cancer Prostate Adenoc...	EPI-7386 Enzalutamide Androgen Depriv...	19 Years -	Case Comprehensive Cancer Center
Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer	NCT06312670	Metastatic Horm... Prostate Cancer Prostate Adenoc...	EPI-7386 Enzalutamide Androgen Depriv...	19 Years -	Case Comprehensive Cancer Center

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