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Study on Androgen Receptor and Triple Negative Breast Cancer (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03383679
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : August 26, 2019
Information provided by (Responsible Party):

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Triple Negative and Androgen Receptor Positive Drug: Darolutamide Drug: Capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : September 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1 Darolutamide
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
Drug: Darolutamide
treatment with darolutamide

Arm 2 Capecitabine

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

Drug: Capecitabine
treatment with capecitabine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. clinical benefit rate [ Time Frame: at 24 weeks ]
    Clinical benefit rate (CBR24)

  2. Objective response rate [ Time Frame: at 16 and 24 weeks ]
    Objective response rate (ORR)

  3. Duration of overall response [ Time Frame: at 16 and 24 weeks ]
    Duration of overall response (DoR)

  4. Overall survival [ Time Frame: at 1 and 2 years ]
    Overall survival (OS)

  5. Progression-free survival [ Time Frame: at 1 and 2 years ]
    Progression-free survival (PFS)

  6. 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 ]
    Evaluation of toxicity in each arm according to CTCAE V4.03

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Woman, ≥ 18 years old;
  2. Histologically confirmed locally recurrent (unresectable) or metastatic breast cancer;
  3. 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;

  4. 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;
  5. 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;
  6. 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);
  7. Presence of measurable or evaluable disease according to RECIST v1.1
  8. ECOG ≤ 1;
  9. Normal hematological function: 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)
  10. Normal hepatic function: total bilirubin ≤ 1.5 upper normal limit (UNL) unless this increase is due to a known Gilbert's disease; ASAT and ALAT ≤ 2.5 UNL (or ≤ 5 UNL in case of hepatic metastasis);
  11. Creatinine clearance (MDRD formula) ≥ 50 mL/min;
  12. 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);
  13. Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;
  14. For premenopausal patients, patient agreeing to use effective contraception during and for ≥ 6 months after completion of study treatment;
  15. Patient able to comply with the protocol;
  16. Patient must have signed a written informed consent form prior to any study specific procedures;
  17. Patient must be affiliated to a Social Health Insurance.

Exclusion Criteria:

  1. HER2-positive status (positivity defined as IHC3+ and/or FISH amplification >2);
  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;
  3. 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 MRI of the brain;
  4. Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
  5. Significant cardiovascular disease, including any of the following:

    1. NYHA class III-IV congestive heart failure
    2. Stroke, unstable angina pectoris or myocardial infarction within the past 6 months
    3. Severe valvular heart disease
    4. Ventricular arrhythmia requiring treatment;
  6. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;
  7. Persistent toxicities grade ≥ 2 from any cause, except chemotherapy-induced alopecia and grade 2 peripheral neuropathy;
  8. Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy;
  9. Any gastrointestinal disorder interfering with absorption of the study drug;
  10. Difficulties with swallowing tablets;
  11. An active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment;
  12. Previous treatment with second-generation AR inhibitors such as enzalutamide, ARN-509, ODM-201, other investigational AR inhibitors CYP17 enzyme inhibitor such as abiraterone, capecitabine…
  13. Patients with known of deficit of dihydropyrimidine dehydrogenase (DPD) activity (see section 4.4) or in case of hypersensitivity to capecitabine or to any of its excipients or to fluorouracil
  14. Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy; chemotherapy within the last 3 weeks (6 weeks for nitrosoureas and mitomycin C), or other investigational agents; concurrent palliative radiotherapy is allowed;
  15. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product;
  16. Pregnant women, women who are likely to become pregnant or are breast-feeding;
  17. 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;
  18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;
  19. Individual deprived of liberty or placed under the authority of a tutor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03383679

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Contact: Sibille EVERHARD, PhD +33 1 73 77 54 33
Contact: Cécile VISSAC-SABATIER, PhD +33 1 73 79 77 58

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Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Christelle LEVY, MD    + 33   
Sponsors and Collaborators
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Study Chair: Hervé BONNEFOI, MD Institut Bergonié - University of Bordeaux 2
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Responsible Party: UNICANCER Identifier: NCT03383679    
Other Study ID Numbers: UC-0140/1711 - UCBG3-06
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents