Breast Cancer FemalePhase 2STARTNCT03383679
Study on Androgen Receptor and Triple Negative Breast Cancer
A Phase 2 study testing Darolutamide and Capecitabine in people with Breast Cancer Female and Triple Negative and Androgen Receptor Positive, run by UNICANCER at 1 site in France.
Trial summary
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Triple Negative and Androgen Receptor Positive
- What is being tested?
- Darolutamide and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2018to 20 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Woman, ≥18 years old;
- Histologically confirmed locally recurrent (unresectable) or metastatic breast cancer;
- Triple negative breast cancer:
- Estrogen receptor (ER)-negative and Progesterone receptor (PgR)-negative, as defined by a <10 % tumor stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from the primary tumour;
- Androgen receptor (AR)-positive, as defined centrally by a ≥ 10% tumor stained cells by IHC Note: AR assessment by local pathologist before inclusion is not mandatory;
- Patients with a relapse or progressive disease should be chemotherapy naïve or have received a maximum of one line of chemotherapy for advanced disease (providing they are not presenting with life-threatening metastasis); patients could have received adjuvant or neo-adjuvant therapy;
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- In the exceptional situation of pre-menopausal patient, the addition of a LHRH analog is recommended (androgens might act as an estrogen antagonist in premenopausal patients);
- Presence of measurable or evaluable disease according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
- Eastern cooperative oncology group (ECOG) ≤1;
- Normal hematological function: Absolute neutrophile count (ANC) ≥1,500/mm³; platelets count ≥100,000/mm³; hemoglobin >10 g/dL; Note: subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
- Normal hepatic function: total bilirubin ≤ 1.5 upper normal limit (UNL) unless this increase is due to a known Gilbert's disease; aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 UNL (or ≤5 UNL in case of hepatic metastasis);
- Creatinine clearance (MDRD formula) ≥50 mL/min;
- Systolic blood pressure (BP) <160 mm Hg and diastolic BP <95 mm Hg, as documented on day of registration/consent (Hypertension allowed provided it is currently controlled);
- Cardiac ejection fraction ≥50% measured by multigated acquisition (MUGA) or echocardiography (ECHO) done within 4 weeks before inclusion;
- For premenopausal patients, patient agreeing to use effective contraception during and for ≥6 months after completion of study treatment;
- Patient able to comply with the protocol;
- Patient must have signed a written informed consent form prior to any study specific procedures;
- Patient must be affiliated to a Social Health Insurance.
Who cannot join
- HER2-positive status (positivity defined as IHC3+ and/or FISH amplification ≥2);
- Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥5 years and patient is deemed to be at low risk for recurrence;
- Active brain metastases or leptomeningeal disease; history of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or Magnetic resonance Imaging (MRI) of the brain;
- Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
- Significant cardiovascular disease, including any of the following:
- NYHA class III-IV congestive heart failure
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- Stroke, unstable angina pectoris or myocardial infarction within the past 6 months
- Severe valvular heart disease
- Ventricular arrhythmia requiring treatment;
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;
- Persistent toxicities grade ≥2 from any cause, except chemotherapy-induced alopecia and grade 2 peripheral neuropathy;
- Any gastrointestinal disorder interfering with absorption of the study drug;
- Difficulties with swallowing tablets;
- An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment;
- PREVIOUS TREATMENT IN THE METASTATIC SETTING: Previous treatment with: capecitabine (MET SETTING), first generation (bicalutamide) or second-generation AR inhibitors (enzalutamide, ARN-509, darolutamide) or other investigational AR inhibitors CYP17 enzyme inhibitor such as abiraterone (capecitabine in the adjuvant setting is allowed provided the last administration was at least ≥12 months prior to study entry)
- Patients with known deficit of dihydropyrimidine dehydrogenase (DPD) activity; or in case of hypersensitivity to capecitabine or to any of its excipients or to fluorouracil;
- Prior anticancer therapy within the last 3 weeks including radiotherapy, endocrine therapy, immunotherapy; chemotherapy (6 weeks for nitrosoureas and mitomycin C), or other investigational agents; concurrent palliative radiotherapy is allowed;
- Concurrent enrolment in another clinical trial in which investigational therapies are administered;
- Pregnant women, women who are likely to become pregnant or are breast-feeding;
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the patient before registration in the trial;
- Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;
- Individual deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2.
The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.
- Being tested
- Darolutamide, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
treatment with darolutamide
CapecitabineDrug
treatment with capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Darolutamide | Experimental | Darolutamib: 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally, continuously until disease progression Receives: Drug: Darolutamide |
| Arm 2 Capecitabine | Other | according to the 3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC3) capecitabine monotherapy is one of the recommended options even in first line (Cardoso et al, 2017).
According to each center policy (minimum 1000 mg/m²) twice daily for 2 weeks followed by 1-week rest period, until progression or unacceptable toxicity Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical benefit rate
The clinical benefit rate (CBR) is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks (CBR16) according to RECIST v1.1
Measured: at 16 weeks
Secondary outcomes (6)
clinical benefit rate
Clinical benefit rate (CBR24)
Measured: at 24 weeks
Objective response rate
Objective response rate (ORR)
Measured: at 16 and 24 weeks
Duration of overall response
Duration of overall response (DoR)
Measured: at 16 and 24 weeks
Overall survival
Overall survival (OS)
Measured: at 1 and 2 years
Progression-free survival
Progression-free survival (PFS)
Measured: at 1 and 2 years
Safety: Evaluation of toxicity in each arm according to CTCAE V4.03
Evaluation of toxicity in each arm according to CTCAE V4.03
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start14 Mar 2018
- Primary completion30 Nov 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé BONNEFOI, MD, Study chair, Institut Bergonié - University of Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383679
- Sponsor's protocol ID
- UC-0140/1711 - UCBG3-06
- Other IDs
- 2017-002284-18, 2017
- Acronym
- START
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2017
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bonnefoi H, Lerebours F, Pulido M, Arnedos M, Tredan O, Dalenc F, Guiu S, Teixeira L, Mollon D, Levy C, Verret B, Dawood H, Deiana L, Mouret Reynier MA, Augereau P, Canon JL, Huchet N, Guyonneau C, Lemonnier J, MacGrogan G, Goncalves A, Darbo E, Iggo R. Darolutamide or capecitabine in triple-negative, androgen receptor-positive, advanced breast cancer (UCBG 3-06 START): a multicentre, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):355-366. doi: 10.1016/S1470-2045(24)00737-X. Epub 2025 Feb 17.
PubMed 39978376
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine
- ClinicalTrials.gov ID
- NCT03383679
- Acronym / sponsor ID
- START / UC-0140/1711 - UCBG3-06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 26 Dec 2017 (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.
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2.
The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Darolutamide | Experimental | Drug: DarolutamideDarolutamib: 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally, continuously until disease progression |
| Arm 2 Capecitabine | Other | Drug: Capecitabineaccording to the 3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC3) capecitabine monotherapy is one of the recommended options even in first line (Cardoso et al, 2017). According to each center policy (minimum 1000 mg/m²) twice daily for 2 weeks followed by 1-week rest period, until progression or unacceptable toxicity |
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)
- Woman, ≥18 years old;
- Histologically confirmed locally recurrent (unresectable) or metastatic breast cancer;
- Triple negative breast cancer:
- Estrogen receptor (ER)-negative and Progesterone receptor (PgR)-negative, as defined by a <10 % tumor stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from the primary tumour;
- Androgen receptor (AR)-positive, as defined centrally by a ≥ 10% tumor stained cells by IHC Note: AR assessment by local pathologist before inclusion is not mandatory;
Key exclusion criteria (22 listed)
- HER2-positive status (positivity defined as IHC3+ and/or FISH amplification ≥2);
- Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥5 years and patient is deemed to be at low risk for recurrence;
- Active brain metastases or leptomeningeal disease; history of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or Magnetic resonance Imaging (MRI) of the brain;
- Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
- Significant cardiovascular disease, including any of the following:
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 |
|---|---|---|
| Darolutamidetreatment with darolutamide | Drug | Arm 1 Darolutamide |
| Capecitabinetreatment with capecitabine | Drug | Arm 2 Capecitabine |
Primary outcome
clinical benefit rate
Time frame: at 16 weeks
The clinical benefit rate (CBR) is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks (CBR16) according to RECIST v1.1
6 secondary outcomes
clinical benefit rate
Time frame: at 24 weeks
Objective response rate
Time frame: at 16 and 24 weeks
Duration of overall response
Time frame: at 16 and 24 weeks
Overall survival
Time frame: at 1 and 2 years
Progression-free survival
Time frame: at 1 and 2 years
Safety: Evaluation of toxicity in each arm according to CTCAE V4.03
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Derived from this study: PubMed 39978376Bonnefoi H, Lerebours F, Pulido M, Arnedos M, Tredan O, Dalenc F, Guiu S, Teixeira L, Mollon D, Levy C, Verret B, Dawood H, Deiana L, Mouret Reynier MA, Augereau P, Canon JL, Huchet N, Guyonneau C, Lemonnier J, MacGrogan G, Goncalves A, Darbo E, Iggo R. Darolutamide or capecitabine in triple-negative, androgen receptor-positive, advanced breast cancer (UCBG 3-06 START): a multicentre, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):355-366. doi: 10.1016/S1470-2045(24)00737-X. Epub 2025 Feb 17.
- 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.
Hervé BONNEFOI, MD study chair
Institut Bergonié - University of Bordeaux 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darolutamide and Capecitabine in people with Breast Cancer Female and Triple Negative and Androgen Receptor Positive, run by UNICANCER at 1 site in France.
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 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: finished, as of the sponsor's last update on 21 Nov 2022. 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 France. 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?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical benefit rate (time frame: at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383679, which also lists 1 linked publication.
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 21 Nov 2022.