Triple Negative Breast CancerPhase 1/24CASTNCT04947189
Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer
A Phase 1/2 study testing Seviteronel-D (Seivteronel in combination with dexamethasone) and Docetaxel in people with Triple Negative Breast Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial summary
To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Seviteronel-D (Seivteronel in combination with dexamethasone) and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2022to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age 18 years or older male or female.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- At least 4 weeks washout period from previous line of treatment, 2 weeks from radiotherapy
- Adequate haematologic and organ function within 14 days before the first study treatment on cycle1, day 1
Show all 13Show fewer
- Life expectancy of at least 3 months
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 28 days after the last dose of seviteronel or, 6 months after the last dose of chemotherapy whichever occurs later.
- Part 1: Histological or cytological-based diagnosis of breast cancer. Any of the three major subtypes of breast cancer is permitted for the phase 1b study, i.e., hormone receptor positive breast cancer i.e. oestrogen and/or progesterone positive in greater than 1% of cells by immunohistochemistry (IHC), or human epidermal growth factor receptor (HER2) positive breast cancer, i.e., IHC 3+ or in situ hybridisation (ISH) positive according to standard ASCO/CAP guidelines or triple-negative breast cancer, i.e., HER2-negative by ASCO/GAO Guidelines and <1% expression of estrogen and/or progesterone receptor by IHC.
- Part 2: Histological or cytological-based diagnosis of triple-negative breast cancer. The tumor must be HER2-negative by ASCO/GAO Guidelines and <1% expression of estrogen and /or progesterone receptor by IHC.
- o The tumor must also show androgen receptor positivity (i.e., AR>0%) by IHC or gene classifier (molecular testing).
- Measurability of lesion: have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1
- Patients must have advanced or recurrent breast cancer pre-inclusion number 8, for whom docetaxel is considered an appropriate treatment option.
Who cannot join
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
- Active infection requiring antibiotics.
- Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.
- Known active tuberculosis.
- Female patients who are pregnant or breast-feeding.
Show all 22Show fewer
- Male or female patients of reproductive potential who are not willing to use effective birth control from screening to 90 days post treatment.
- Women of childbearing potential (who are not postmenopausal within 12 months of non-therapy induced amenorrhea, nor surgically sterile) must have a negative serum pregnancy test result within 3 days prior to initiation of study treatment.
- Uncontrolled intercurrent illness, including psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events, or compromise the ability of the subject to give written informed consent.
- History or current evidence of HIV infection.
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (e.g., positive for hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV] antibody at screening), current drug or alcohol abuse, or cirrhosis:
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible.
- Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the course of the study
- Placement of a vascular access device is not considered major surgery.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Patients with symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not receiving corticosteroids and/or anticonvulsants for at least 7 days prior to first dose of study treatment, and their disease is asymptomatic and radiographically stable for at least 30 days prior to consent by repeat imaging (repeat imaging should be performed during study screening).
- Unresolved, clinically significant toxicity NCI CTCAE v5.0 grade 2 or higher, from prior therapy, except for alopecia, endocrinopathy on stable hormonal replacement, and others as approved by study PI.
- Patients who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Known hypersensitivity or contraindication to any component of the study treatment.
- Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Rachel Dear, MD
About this study
Official title: 4CAST: A Phase 1b Dose Exploration and Dose Expansion, Open-label, Single-centre Study Evaluating the Safety and Efficacy of INO-464 in Combination With Chemotherapy in Patients With metASTatic Breast Cancer
To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
Read the detailed description
Background:
Triple-negative breast cancer (TNBC) accounts for approximately 15-20% of all breast cancers and is defined by the absence of immunostaining for estrogen receptor (ER), progesterone receptor (PR), and non-amplified HER2 expression. Patients with metastatic TNBC exhibit a particularly poor clinical outcome, generally with rapid progression and a median overall survival (OS) rate of approximately 16 months. The current standard of care in the treatment of TNBC is cytotoxic chemotherapy and immunotherapy and the development of well-tolerated, effective, and targeted regimens that delay the need for cytotoxic chemotherapy and its side effects is an unmet need. Understanding breast cancer heterogeneity has enabled investigators to identify novel targets for the development of new therapeutic interventions. The androgen receptor (AR) is one such target. AR is expressed in 70-90% of all invasive breast cancers. Emerging data suggest that the AR-signalling pathway may play a critical role in breast cancer pathogenesis. Seviteronel is an orally bioavailable, selective cytochrome P450c17a (CYP17) lyase (lyase) and AR inhibitor. It is approximately 10-fold more selective for CYP17 lyase versus CYP17 17-α hydroxylase (hydroxylase) inhibition. Seviteronel inhibits the AR through competitive antagonism of both wild-type and mutated forms of the receptor. Through this unique, dual mechanism of action, it inhibits androgen production, thus reducing downstream estrogen aromatization from androgens, while also inhibiting AR binding and activation. In our own unpublished work, the investigators have shown that AR expression is often present in the cytoplasm of TNBC cells. When scoring patient samples for cytoplasmic AR, the investigators observed that ~cytoplasmic AR was present in 20% of TNBC patient tumours. This suggests that AR-targeted therapies may be beneficial for a far greater number of TNBC patients than is represented by the traditionally defined triple negative breast cancer AR subtype alone. Seviteronel has been shown to inhibit the growth in multiple breast cancer models, both in vitro and in vivo. Three early-phase prospective clinical studies investigating anti-androgen therapy have demonstrated clinical benefit of single-agent AR-targeted agents in women with metastatic AR positive TNBC. In our preliminary laboratory data (unpublished) demonstrates an increase in survival and suppression of metastatic TNBC when seviteronel is used in combination with docetaxel.
Aim:
To determine the feasibility, safety and efficacy of seviteronel and dexamethasone (SEVI-D) in combination with chemotherapy for the treatment of metastatic breast cancer. This study is conducted in two parts: part 1: dose exploration, and part 2: dose expansion.
Objectives:
To evaluate the safety and tolerability of SEVI-D and chemotherapy (docetaxel) in patients with metastatic breast cancer and determine the recommended phase II dose (RP2D) for SEVI-D/docetaxel combination therapy.
Part 1: Metastatic breast cancer
- To assess the pharmacokinetic and pharmacodynamic profiles of SEVI-D and chemotherapy (docetaxel) in metastatic breast cancer.
Part 2: Androgen receptor-positive metastatic triple-negative breast cancer
- To assess the pharmacokinetic and pharmacodynamic profiles of SEVI-D and chemotherapy (docetaxel).
- To evaluate the clinical activity SEVI-D and chemotherapy (docetaxel) in participants with cytoplasmic androgen receptor-positive metastatic triple negative breast cancer.
Design and sample size:
Part 1: Dose exploration - 6- 18 patients based on a rolling 6 design Part 2: Dose expansion - 35-45 patients in a single arm two-stage investigation
Study population:
Part 1: Patients with metastatic breast cancer. Part 2: Patients with cytoplasmic AR-positive metastatic triple-negative breast cancer confirmed by immunohistochemistry.
Study treatment:
Part 1: Seviteronel will be administered orally beginning with 450 mg (3 x 150 mg tablets) once daily along with 0.5 mg dexamethasone, continuously in 28-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly.
Part 2: The recommended phase 2 dose for seviteronel (established in Part 1) once daily along with 0.5 mg dexamethasone, continuously in 21-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly.
Screening for participation includes review of patient history, current health status, availability of a biospecimen for AR screening and patient willingness to be in a trial if eligible. Clinical and safety assessments are scheduled prior to registration and every 8 weeks until death. Imaging and other response assessments are required at baseline and every 2 cycles from cycle 1 day 1 until progression. Blood collection for translational studies will occur at: baseline (collected within 21 days prior to registration) or within 28 days of C1D1 treatment, every 2nd cycle and at the end of treatment.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Seviteronel-D (Seivteronel in combination with dexamethasone), Docetaxel
- Keywords
- Androgen receptor positive
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seviteronel-D (Seivteronel in combination with dexamethasone)Drug
Also called INO-464
Use of Seviteronel-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.
DocetaxelDrug
Use of docetaxel chemotherapy for solid tumours
| Study group | Role | What they receive |
|---|---|---|
| Seviteronel, dexamethasone and docetaxel | Experimental | Part 1: Seviteronel will be administered orally beginning with 450 mg (3 x 150 mg tablets) once daily along with 0.5 mg dexamethasone, continuously in 28-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly.
Part 2: The recommended phase 2 dose for seviteronel (established in Part 1) once daily along with 0.5 mg dexamethasone, continuously in 21-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly. Receives: Drug: Seviteronel-D (Seivteronel in combination with dexamethasone); Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 dose of seviteronel plus dexamethasone and docetaxel
A patient will be considered evaluable for dose limiting toxicity (DLT) if they have completed two cycles of docetaxel in an 8-week period with at least 80% of the planned INO-464 dose. Toxicity will be graded using CTCAE version 5.0
Measured: 10 weeks
Secondary outcomes (4)
Number of patients with treatment-related adverse events
Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v5.0
Measured: 2 years
Overall response rate (ORR)
The proportion of patients with a confirmed complete response or partial response as determined by the investigator according to RECIST v1.1
Measured: 2 years
Duration of response (DoR)
The time from the first occurrence of a documented confirmed complete response or partial response to the first date of recorded disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)
Measured: 2 years
Overall survival (OS)
The time from starting the study treatment to death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Nov 2022
- Primary completionJul 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Joshua, FRACP, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947189
- Sponsor's protocol ID
- 4CAST
- Acronym
- 4CAST
- Status last verified
- May 2025
- First submitted
- 25 Mar 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4CAST: A Phase 1b Dose Exploration and Dose Expansion, Open-label, Single-centre Study Evaluating the Safety and Efficacy of INO-464 in Combination With Chemotherapy in Patients With metASTatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04947189
- Acronym / sponsor ID
- 4CAST / 4CAST
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Androgen receptor positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.
Detailed description
Background:
Triple-negative breast cancer (TNBC) accounts for approximately 15-20% of all breast cancers and is defined by the absence of immunostaining for estrogen receptor (ER), progesterone receptor (PR), and non-amplified HER2 expression. Patients with metastatic TNBC exhibit a particularly poor clinical outcome, generally with rapid progression and a median overall survival (OS) rate of approximately 16 months. The current standard of care in the treatment of TNBC is cytotoxic chemotherapy and immunotherapy and the development of well-tolerated, effective, and targeted regimens that delay the need for cytotoxic chemotherapy and its side effects is an unmet need. Understanding breast cancer heterogeneity has enabled investigators to identify novel targets for the development of new therapeutic interventions. The androgen receptor (AR) is one such target. AR is expressed in 70-90% of all invasive breast cancers. Emerging data suggest that the AR-signalling pathway may play a critical role in breast cancer pathogenesis. Seviteronel is an orally bioavailable, selective cytochrome P450c17a (CYP17) lyase (lyase) and AR inhibitor. It is approximately 10-fold more selective for CYP17 lyase versus CYP17 17-α hydroxylase (hydroxylase) inhibition. Seviteronel inhibits the AR through competitive antagonism of both wild-type and mutated forms of the receptor. Through this unique, dual mechanism of action, it inhibits androgen production, thus reducing downstream estrogen aromatization from androgens, while also inhibiting AR binding and activation. In our own unpublished work, the investigators have shown that AR expression is often present in the cytoplasm of TNBC cells. When scoring patient samples for cytoplasmic AR, the investigators observed that ~cytoplasmic AR was present in 20% of TNBC patient tumours. This suggests that AR-targeted therapies may be beneficial for a far greater number of TNBC patients than is represented by the traditionally defined triple negative breast cancer AR subtype alone. Seviteronel has been shown to inhibit the growth in multiple breast cancer models, both in vitro and in vivo. Three early-phase prospective clinical studies investigating anti-androgen therapy have demonstrated clinical benefit of single-agent AR-targeted agents in women with metastatic AR positive TNBC. In our preliminary laboratory data (unpublished) demonstrates an increase in survival and suppression of metastatic TNBC when seviteronel is used in combination with docetaxel.
Aim:
To determine the feasibility, safety and efficacy of seviteronel and dexamethasone (SEVI-D) in combination with chemotherapy for the treatment of metastatic breast cancer. This study is conducted in two parts: part 1: dose exploration, and part 2: dose expansion.
Objectives:
To evaluate the safety and tolerability of SEVI-D and chemotherapy (docetaxel) in patients with metastatic breast cancer and determine the recommended phase II dose (RP2D) for SEVI-D/docetaxel combination therapy.
Part 1: Metastatic breast cancer
- To assess the pharmacokinetic and pharmacodynamic profiles of SEVI-D and chemotherapy (docetaxel) in metastatic breast cancer.
Part 2: Androgen receptor-positive metastatic triple-negative breast cancer
- To assess the pharmacokinetic and pharmacodynamic profiles of SEVI-D and chemotherapy (docetaxel).
- To evaluate the clinical activity SEVI-D and chemotherapy (docetaxel) in participants with cytoplasmic androgen receptor-positive metastatic triple negative breast cancer.
Design and sample size:
Part 1: Dose exploration - 6- 18 patients based on a rolling 6 design Part 2: Dose expansion - 35-45 patients in a single arm two-stage investigation
Study population:
Part 1: Patients with metastatic breast cancer. Part 2: Patients with cytoplasmic AR-positive metastatic triple-negative breast cancer confirmed by immunohistochemistry.
Study treatment:
Part 1: Seviteronel will be administered orally beginning with 450 mg (3 x 150 mg tablets) once daily along with 0.5 mg dexamethasone, continuously in 28-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly.
Part 2: The recommended phase 2 dose for seviteronel (established in Part 1) once daily along with 0.5 mg dexamethasone, continuously in 21-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly.
Screening for participation includes review of patient history, current health status, availability of a biospecimen for AR screening and patient willingness to be in a trial if eligible. Clinical and safety assessments are scheduled prior to registration and every 8 weeks until death. Imaging and other response assessments are required at baseline and every 2 cycles from cycle 1 day 1 until progression. Blood collection for translational studies will occur at: baseline (collected within 21 days prior to registration) or within 28 days of C1D1 treatment, every 2nd cycle and at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seviteronel, dexamethasone and docetaxel | Experimental | Drug: Seviteronel-D (Seivteronel in combination with dexamethasone), Drug: DocetaxelPart 1: Seviteronel will be administered orally beginning with 450 mg (3 x 150 mg tablets) once daily along with 0.5 mg dexamethasone, continuously in 28-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly. Part 2: The recommended phase 2 dose for seviteronel (established in Part 1) once daily along with 0.5 mg dexamethasone, continuously in 21-day cycles with docetaxel 75mg/m2 administered intravenously 3 weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written and voluntary informed consent.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Age 18 years or older male or female.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- At least 4 weeks washout period from previous line of treatment, 2 weeks from radiotherapy
Key exclusion criteria (22 listed)
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
- Active infection requiring antibiotics.
- Other invasive malignancy within 2 years except for malignancies determined to have low recurrence potential in discussion with study PI.
- Known active tuberculosis.
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 |
|---|---|---|
| Seviteronel-D (Seivteronel in combination with dexamethasone)Also: INO-464Use of Seviteronel-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours. | Drug | Seviteronel, dexamethasone and docetaxel |
| DocetaxelUse of docetaxel chemotherapy for solid tumours | Drug | Seviteronel, dexamethasone and docetaxel |
Primary outcome
Recommended phase 2 dose of seviteronel plus dexamethasone and docetaxel
Time frame: 10 weeks
A patient will be considered evaluable for dose limiting toxicity (DLT) if they have completed two cycles of docetaxel in an 8-week period with at least 80% of the planned INO-464 dose. Toxicity will be graded using CTCAE version 5.0
4 secondary outcomes
Number of patients with treatment-related adverse events
Time frame: 2 years
Overall response rate (ORR)
Time frame: 2 years
Duration of response (DoR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Related trials for Triple Negative Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Seviteronel-D (Seivteronel in combination with dexamethasone) and Docetaxel in people with Triple Negative Breast Cancer, run by St Vincent's Hospital, Sydney at 1 site in Australia.
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 13 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel F Dear, PhD (+61293553633, rachel.dear@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase 2 dose of seviteronel plus dexamethasone and docetaxel (time frame: 10 weeks). 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 15 May 2025.