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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.

The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.

The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%.

A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.

Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

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Site IRB:
22-011685
NCT ID:
NCT05607004
Sponsor Protocol Number:
ATOS-Z-201

A Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer

Rochester, MN
- See Details
A Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

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Site IRB:
25-006670

NCT ID:
NCT07460752

Sponsor Protocol Number:
MC250301

Mayo Clinic Location	Status	Contact
Rochester, MN	Open for enrollment	View complete study & contact information

A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, AZ	Open for enrollment
Eau Claire, WI	Open for enrollment
Jacksonville, FL	Open for enrollment
La Crosse, WI	Open for enrollment
Mankato, MN	Open for enrollment
Rochester, MN	Open for enrollment

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Site IRB:
24-012591
NCT ID:
NCT06492616
Sponsor Protocol Number:
STML-ELA-0422

Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors

Albert Lea, MN, Mankato, MN, Rochester, MN

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Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but have been shown to improve quality of life, muscular strength, pain, and flexibility. Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Open for enrollment	View complete study & contact information
Mankato, MN	Open for enrollment
Rochester, MN	Contact us for the latest status

Print study details

Site IRB:
23-005266
NCT ID:
NCT06028022
Sponsor Protocol Number:
MC221002

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Scottsdale/Phoenix, AZ, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
24-000635
NCT ID:
NCT05879926
Sponsor Protocol Number:
NRG-BR009

Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia

Albert Lea, MN, Mankato, MN, Rochester, MN

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Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment. This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Open for enrollment	View complete study & contact information
Mankato, MN	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
22-004341
NCT ID:
NCT05612100
Sponsor Protocol Number:
MC220902

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Search Results 1-6 of 6 for

(Z)-Endoxifen For The Treatment Of Premenopausal Women With ER+/HER2- Breast Cancer

A Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer

A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence

Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia

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