Active — Not RecruitingPhase 1

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

United States396 participantsStarted 2018-10-11

Plain-language summary

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)

Who can participate

Age range18 Years – 130 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written informed consent.
✓. \>= 18 years
✓. Any menopausal status:
✓. Pre-menopausal women must have commenced treatment with an LHRH agonist at least 4 weeks prior to starting AZD9833 (± combination IMP(s)) and must be willing to continue to receive LHRH agonist therapy for the duration of the study
✓. Post-menopausal defined according to standard criteria in the protocol.
✓. Histological or cytological confirmation of adenocarcinoma of the breast
✓. Documented positive oestrogen receptor status of primary or metastatic tumour tissue, according to the local laboratory parameters.HER-2 negative.
✓. Metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit

Exclusion criteria

✕. Intervention with any of the following
✕. Any cytotoxic chemotherapy, investigational agents/other anti-cancer drugs for the treatment of advanced breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of IMP
✕. Concomitant medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 (CYP) 3A4/5, sensitive CYP2B6 substrates, and drugs which are sensitive substrates of CYP2C9 and/or CYP2C19, and which have a narrow therapeutic index. In addition: Parts E and F will exclude the concomitant use of moderate CYP3A4 and/or Pgp inhibitors; Parts G H, I, J, K and L will exclude the concomitant use of moderate CYP3A4/5 inhibitors and inducers; Parts I and J will exclude concomitant use of sensitive substrates of CYP3A4 and/or CYP2D6 with a narrow therapeutic index."
✕. Drugs known to prolong QT and known risk of Torsades de Pointes
✕. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of IMP, except patients receiving radiotherapy to more than 30% of the bone marrow/a wide field of radiation within 4 weeks of the first dose of IMP
✕. Major surgical procedure/significant traumatic injury, as judged by the investigator, within 4 weeks of the first dose of IMP, or an anticipated need for major surgery and/or any surgery requiring general anaesthesia during the study.
✕. Any unresolved toxicities from prior therapy \> CTCAE Grade 1 at the time of starting IMP, with the exception of alopecia.
✕. Presence of life-threatening metastatic visceral disease, as judged by the investigator, uncontrolled CNS metastatic disease. Patients with spinal cord compression and/or brain metastases may be enrolled if definitively treated (eg, surgery or radiotherapy) and stable off steroids for at least 4 weeks prior to start of IMP

What they're measuring

The number of subjects with dose-limiting toxicity, as defined in the protocol.

Timeframe: Minimum observation period 28 days on treatment.

The number of subjects with treatment-related adverse events as assessed by CTCAE v4.03.

Timeframe: Minimum observation period 28 days on treatment, and will continue until the subject is off the study (approximately 1 year).

Trial details

NCT IDNCT03616587

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-16

View on ClinicalTrials.gov More ER+ HER2- Advanced Breast Cancer trials