Breast Cancer FemaleEarly Phase 1NCT03004534
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
A Early Phase 1 study testing darolutamide in people with Breast Cancer Female, run by Translational Research in Oncology at 14 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- darolutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 5 Sep 2017to 13 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.
- Female ≥ 18 years old.
- Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.
- Known ER, PgR and HER2 statuses.
- Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):
- T1 with T ≥1.0cm, T2 or T3 by at least one radiographic or clinical measurement
Show all 18Show fewer
- Either clinically positive (N1 only) or clinically negative axillary nodes (N0)
- M0
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:
- Hematology: Hemoglobin ≥ 9.0 g/dl; ANC ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L
- Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (or ≤ 3 times ULN for patients with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)
- Renal function: Creatinine ≤ 2.0 × ULN
- No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the day of the first intake of darolutamide.
- Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of darolutamide.
- For WoCBP* negative serum pregnancy test within 7 days of enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.
- Note: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age ≥ 60; Age < 60 and amenorrheic for ≥ 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.
Who cannot join
- Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.
- Bilateral invasive BC.
- Patient that underwent excisional biopsy of the primary tumor.
- Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.
- Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).
- Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.
Show all 20Show fewer
- Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).
- Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.
- Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.
- Use of other investigational drug within 28 days of enrollment.
- Major surgery* within 28 days before enrollment.
- Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A patient with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.
- Severe or uncontrolled concurrent disease, infection or comorbidity.
- Known active viral hepatitis, HIV or chronic liver disease.
- Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.
- Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Known allergy to darolutamide or any of the excipients.
- Pregnant or lactating darolutamide. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada6 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
(CIUSSS) de l'Est-de-l'Île-de-Montréal - l'Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Jewish General Hospital
Montreal, Quebec, H3T1E2
McGill University Hospital
Montreal, Quebec, H4A 3J1
Centre Hospitalier Affilie Universitaire De Quebec - Hospital Du Saint-Sacrement
Québec, Quebec, G1S 4L8
United States5 sites
UCLA
Los Angeles, California, 90095-1678
Valley Breast Care and Women's Health Center
Los Angeles, California, 91405
UF Health Cancer Center - Orlando Health
Orlando, Florida, 32806
Torrance Memorial Physician Network, Cancer Care Associates
Redondo Beach, California, 90277
Central Coast Medical Oncology
Santa Maria, California, 93454
Germany3 sites
Universitatsklinikum Erlangen
Erlangen, 91054
Interdisziplinares Onkologisches Zentrum
München, 80336
Department of Women's Health
Tübingen, 72076
About this study
Official title: A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects.
The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
Read the detailed description
This current study will enroll EBC subjects with differing breast cancer (BC) subtypes, with the intent of characterizing the molecular alterations in BC tissue before and after short-term exposure to the anti-androgen darolutamide. Studying the biological mechanisms in which darolutamide targets the androgen receptor (AR) in BC will be crucial in understanding its' potential role, as well as provide the foundation for further development of darolutamide in this disease.
TRIO030 will evaluate the following objectives: Primary -To identify the molecular alterations that occur in human BC tissue, following short-term exposure to darolutamide in female subjects with EBC; Secondary - To evaluate the safety and tolerability of short-term exposure to darolutamide in female subjects with EBC.
Design: This will be a multi-center, open-label, tissue-acquisition study involving up to 60 subjects from approximately 20 sites in North America and Europe, and will enroll EBC subjects of differing subtypes (i.e., triple negative [TNBC], ER+/HER2-, and HER2+), with the intent of characterizing the molecular alterations in BC tissue before and after short-term exposure to the anti-androgen darolutamide.
Such information may suggest that darolutamide be combined with other modalities; for example, if treatment with the drug is discovered to affect multiple signaling pathways. Molecular profiling of tumor samples before and after darolutamide treatment may permit the identification of patients likely or unlikely to respond to the agent based on the biological and molecular characteristics of their tumors.
Duration: It is recommended that the surgery date is defined prior to starting protocol treatment and then the start date of darolutamide (Day 1) will be derived as minus 14 to 21 days from the scheduled surgery date. Treatment will be taken until the day prior to surgery or when the subject is ordered to stop all oral intake (i.e., "nil per os" (npo)), which ever occurs first. If for some reason surgery takes place more than 21 days after treatment start, it is acceptable that the subject receives darolutamide for more than 21 days and up to a maximum of 35 days; subject should continue protocol treatment until the day prior to surgery, or npo is ordered. In these cases it is strongly recommended to have surgery performed as soon as possible after 21 days of treatment are completed.
After surgery, an End of Study (EoS) visit will occur 30 days (+/- 3 days) after the subject's last intake of darolutamide. In case of ongoing protocol treatment-related AEs/SAEs at the time of the EoS visit, monitoring of these events will continue as clinically indicated until (a) the events have resolved or (b) the events have reached a status which, in the Investigator's opinion, is unlikely to resolve due to the nature of the condition and/or the subject's underlying disease.
Total Number of Sites: A total of 14 sites were opened worldwide, with 5 sites located within the U.S, 6 in Canada, and 3 in Germany.
Sample Size/Patient Population: Up to 60 subjects will be enrolled in the study. To be able to assess the molecular alterations after darolutamide, exposure in different BC subtypes, subjects being either triple-negative, or ER+/HER2 negative, or HER2 positive, will be enrolled in the study. Up to 20 subjects with each of these subtypes will be included (with an acceptable minimum of 8 evaluable patients in each cohort).
Dosage Regimen: Darolutamide will be given at a dose of 600 mg (2 x 300 mg tablets) twice daily (b.i.d) to a daily dose of 1200 mg.
The first day of darolutamide administration in the study is considered Day 1. The last darolutamide intake will be on the day prior to breast cancer surgery, when the pre-surgery visit should occur.
darolutamide should be taken approximately at the same time each day twice a day. It is recommended that darolutamide be taken with food; recommendation is to take it with breakfast and dinner each day.
Supportive measures and dose modifications: A subject who experiences a treatment-related grade 3 or higher adverse event (AE) must be withdrawn from protocol treatment and should proceed to surgery and undergo an EoS visit. In the case of a grade 1-2 treatment-related AE, the Investigator should contact the Medical Monitor if a dose reduction or treatment hold is required.
Washout pre-trial: Prior treatment of ovarian hormone replacement therapy should be stopped at least 28 days prior to registration. Use of other investigational drugs should be stopped within 28 days of enrollment. No major surgery within 28 days before enrollment (Major surgery is defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability).
Concomitant Medication: Subjects will be instructed to consult with the Investigator before taking any medications (including over-the-counter medications). Supportive medications may be provided prophylactically or therapeutically per Investigator discretion.
Any concomitant treatment NOT listed below is considered permitted in the study and may be prescribed as clinically appropriate during the study:
- Investigational agents other than the protocol treatment.
- Any additional standard or investigational anticancer agents, such as chemotherapy, immunotherapy, targeted/biologic therapy, endocrine therapy, etc., even if utilized as treatment of non-cancer indications. darolutamide must be permanently discontinued upon initiation of a non-protocol standard or investigational antineoplastic therapy prior to surgery.
Rescue Medication and Risk Management: No specific pre-medication is required. Based on the current available data , there are no special warnings and precautions associated with the use of darolutamide.
Premature Withdrawal / Discontinuation Criteria: The patient may withdraw from the study at any time without prejudicing future medical treatment. In any case, the withdrawal should be clearly documented in the subject's clinical records.
Should a patient decide to withdraw consent, all efforts will be made to complete and report the observations as thoroughly as possible. A complete final evaluation at the time of the patient's withdrawal should be made with an explanation of why the patient is withdrawing from the study. After complete withdrawal of consent, no further study procedure is performed and no further data will be collected.
Discontinuation: The Investigator will also discontinue protocol treatment if any of the following conditions is met:
- Intercurrent illness or a change in subject´s condition or unacceptable toxicity that warrants protocol treatment discontinuation according to Investigator's judgment
- Any event, condition, criterion which would warrant discontinuation of darolutamide (i.e., severe toxicities), including grade ≥ 3 protocol-treatment related AE
- Any event, condition, reason which would warrant darolutamide to be held for more than the maximum acceptable delay of 7 consecutive days
- Subject receives non-protocol anti-cancer therapy at any time during the protocol treatment
- Subject's decision to withdraw protocol treatment
- Lost to follow up
- Death
- Pregnancy
- Investigator's decision
- Discontinuation of the study by the sponsor
- Patient is enrolled but does not receive protocol treatment for any reason
- Conditions
- Breast Cancer Female
- Being tested
- darolutamide
- Keywords
- Breast Cancer, Breast Carcinoma, Breast Tumours, Early Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darolutamideDrug
Also called BAY 1841788, ODM-201
Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Presurgical Molecular Assessment | Experimental | Oral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d. Receives: Drug: darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.
Androgen Receptor (AR) was assessed on the collected samples.
Measured: 1 year, 6 months
Secondary outcomes (1)
Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03
The assessment of safety will be performed for all subjects who have taken at least one tablet of darolutamide (defined as the "safety population")
Measured: 1 year, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start5 Sep 2017
- Primary completion14 Feb 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Rodrigo Fresco, MD, Study director, Translational Research in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004534
- Sponsor's protocol ID
- TRIO030
- Other IDs
- 2016-004151-79, HC6-24-c 201058, 2016
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2016
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)
- ClinicalTrials.gov ID
- NCT03004534
- Acronym / sponsor ID
- TRIO030
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer, Breast Carcinoma, Breast Tumours, Early Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Translational Research in OncologyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of short-term treatment with darolutamide on breast cancer cells (i.e., how the treatment may change the genes or proteins in breast cancer cells) and to evaluate its safety and the way it is tolerated by subjects.
The intent is to study these changes in order to have a better understanding of the potential use of darolutamide for women with EBC, know which patients are likely or unlikely to respond to this treatment, and determine how darolutamide may be combined with other anti-cancer drugs.
Detailed description
This current study will enroll EBC subjects with differing breast cancer (BC) subtypes, with the intent of characterizing the molecular alterations in BC tissue before and after short-term exposure to the anti-androgen darolutamide. Studying the biological mechanisms in which darolutamide targets the androgen receptor (AR) in BC will be crucial in understanding its' potential role, as well as provide the foundation for further development of darolutamide in this disease.
TRIO030 will evaluate the following objectives: Primary -To identify the molecular alterations that occur in human BC tissue, following short-term exposure to darolutamide in female subjects with EBC; Secondary - To evaluate the safety and tolerability of short-term exposure to darolutamide in female subjects with EBC.
Design: This will be a multi-center, open-label, tissue-acquisition study involving up to 60 subjects from approximately 20 sites in North America and Europe, and will enroll EBC subjects of differing subtypes (i.e., triple negative [TNBC], ER+/HER2-, and HER2+), with the intent of characterizing the molecular alterations in BC tissue before and after short-term exposure to the anti-androgen darolutamide.
Such information may suggest that darolutamide be combined with other modalities; for example, if treatment with the drug is discovered to affect multiple signaling pathways. Molecular profiling of tumor samples before and after darolutamide treatment may permit the identification of patients likely or unlikely to respond to the agent based on the biological and molecular characteristics of their tumors.
Duration: It is recommended that the surgery date is defined prior to starting protocol treatment and then the start date of darolutamide (Day 1) will be derived as minus 14 to 21 days from the scheduled surgery date. Treatment will be taken until the day prior to surgery or when the subject is ordered to stop all oral intake (i.e., "nil per os" (npo)), which ever occurs first. If for some reason surgery takes place more than 21 days after treatment start, it is acceptable that the subject receives darolutamide for more than 21 days and up to a maximum of 35 days; subject should continue protocol treatment until the day prior to surgery, or npo is ordered. In these cases it is strongly recommended to have surgery performed as soon as possible after 21 days of treatment are completed.
After surgery, an End of Study (EoS) visit will occur 30 days (+/- 3 days) after the subject's last intake of darolutamide. In case of ongoing protocol treatment-related AEs/SAEs at the time of the EoS visit, monitoring of these events will continue as clinically indicated until (a) the events have resolved or (b) the events have reached a status which, in the Investigator's opinion, is unlikely to resolve due to the nature of the condition and/or the subject's underlying disease.
Total Number of Sites: A total of 14 sites were opened worldwide, with 5 sites located within the U.S, 6 in Canada, and 3 in Germany.
Sample Size/Patient Population: Up to 60 subjects will be enrolled in the study. To be able to assess the molecular alterations after darolutamide, exposure in different BC subtypes, subjects being either triple-negative, or ER+/HER2 negative, or HER2 positive, will be enrolled in the study. Up to 20 subjects with each of these subtypes will be included (with an acceptable minimum of 8 evaluable patients in each cohort).
Dosage Regimen: Darolutamide will be given at a dose of 600 mg (2 x 300 mg tablets) twice daily (b.i.d) to a daily dose of 1200 mg.
The first day of darolutamide administration in the study is considered Day 1. The last darolutamide intake will be on the day prior to breast cancer surgery, when the pre-surgery visit should occur.
darolutamide should be taken approximately at the same time each day twice a day. It is recommended that darolutamide be taken with food; recommendation is to take it with breakfast and dinner each day.
Supportive measures and dose modifications: A subject who experiences a treatment-related grade 3 or higher adverse event (AE) must be withdrawn from protocol treatment and should proceed to surgery and undergo an EoS visit. In the case of a grade 1-2 treatment-related AE, the Investigator should contact the Medical Monitor if a dose reduction or treatment hold is required.
Washout pre-trial: Prior treatment of ovarian hormone replacement therapy should be stopped at least 28 days prior to registration. Use of other investigational drugs should be stopped within 28 days of enrollment. No major surgery within 28 days before enrollment (Major surgery is defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability).
Concomitant Medication: Subjects will be instructed to consult with the Investigator before taking any medications (including over-the-counter medications). Supportive medications may be provided prophylactically or therapeutically per Investigator discretion.
Any concomitant treatment NOT listed below is considered permitted in the study and may be prescribed as clinically appropriate during the study:
- Investigational agents other than the protocol treatment.
- Any additional standard or investigational anticancer agents, such as chemotherapy, immunotherapy, targeted/biologic therapy, endocrine therapy, etc., even if utilized as treatment of non-cancer indications. darolutamide must be permanently discontinued upon initiation of a non-protocol standard or investigational antineoplastic therapy prior to surgery.
Rescue Medication and Risk Management: No specific pre-medication is required. Based on the current available data , there are no special warnings and precautions associated with the use of darolutamide.
Premature Withdrawal / Discontinuation Criteria: The patient may withdraw from the study at any time without prejudicing future medical treatment. In any case, the withdrawal should be clearly documented in the subject's clinical records.
Should a patient decide to withdraw consent, all efforts will be made to complete and report the observations as thoroughly as possible. A complete final evaluation at the time of the patient's withdrawal should be made with an explanation of why the patient is withdrawing from the study. After complete withdrawal of consent, no further study procedure is performed and no further data will be collected.
Discontinuation: The Investigator will also discontinue protocol treatment if any of the following conditions is met:
- Intercurrent illness or a change in subject´s condition or unacceptable toxicity that warrants protocol treatment discontinuation according to Investigator's judgment
- Any event, condition, criterion which would warrant discontinuation of darolutamide (i.e., severe toxicities), including grade ≥ 3 protocol-treatment related AE
- Any event, condition, reason which would warrant darolutamide to be held for more than the maximum acceptable delay of 7 consecutive days
- Subject receives non-protocol anti-cancer therapy at any time during the protocol treatment
- Subject's decision to withdraw protocol treatment
- Lost to follow up
- Death
- Pregnancy
- Investigator's decision
- Discontinuation of the study by the sponsor
- Patient is enrolled but does not receive protocol treatment for any reason
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presurgical Molecular Assessment | Experimental | Drug: darolutamideOral 300 mg darolutamide tablet; dose of 600 mg (2 x 300 mg tablets) b.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.
- Female ≥ 18 years old.
- Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.
- Known ER, PgR and HER2 statuses.
- Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):
Key exclusion criteria (20 listed)
- Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.
- Bilateral invasive BC.
- Patient that underwent excisional biopsy of the primary tumor.
- Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.
- Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darolutamideAlso: BAY 1841788, ODM-201Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg. | Drug | Presurgical Molecular Assessment |
Primary outcome
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.
Time frame: 1 year, 6 months
Androgen Receptor (AR) was assessed on the collected samples.
1 secondary outcome
Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03
Time frame: 1 year, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Fresco, MD study director
Translational Research in Oncology
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing darolutamide in people with Breast Cancer Female, run by Translational Research in Oncology at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer. (time frame: 1 year, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.