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AzTrials

Breast CancerPhase 1/2NCT00755885

Abiraterone Acetate in Treating Postmenopausal Women With Advanced or Metastatic Breast Cancer

A Phase 1/2 study testing abiraterone acetate, laboratory biomarker analysis and pharmacogenomic studies in people with Breast Cancer, run by Cancer Research UK at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone acetate and to see how well it works in treating postmenopausal women with advanced or metastatic breast… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
abiraterone acetate, laboratory biomarker analysis and pharmacogenomic studies
How many people
77 participants
Where
6 sitesUnited Kingdom
Study dates
Oct 2008to 4 Jun 2016
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed advanced or metastatic breast carcinoma
  • Evidence of disease progression (off treatment) prior to trial commencement.
  • All patients must have received previous treatment in the adjuvant or metastatic setting:
  • ER+ patients must have received at least two types of hormone therapy (e.g. aromatase inhibitors and Tamoxifen)
  • HER2+ patients must have received Herceptin plus at least one other line of chemotherapy
  • HER - ER- patients must have received at least one line of chemotherapy
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  • Post-menopausal defined by:
  • Aged > 60 years or
  • Aged 45-59 years with intact uterus and amenorrhoeic for at least 12 months or
  • Aged > 40 years (has not received chemotherapy in the past 12 months) and no menstrual periods for 12 consecutive months (no other biological/physiological cause identified) and hormone levels are consistent with post menopausal status or
  • Aged > 18 years having had a bilateral surgical oophorectomy.
  • Either ER+ (any AR) or AR+ (ER-) disease (by immunohistochemistry)
  • For Phase II only: Measurable disease by RECIST criteria.
  • Life expectancy of at least 3 months.
  • World Health Organization (WHO) performance status of 0-2 (Appendix 1).
  • Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before the patient goes on study.
  • Lab Test Value required Haemoglobin (Hb) ≥9.0 g/dl Neutrophils ≥1.5 x 10^9/L Platelets ≥100 x 10^9/L Total bilirubin ≤1.5 x upper normal limit (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (5 x ULN in the presence of liver metastases) Creatinine clearance
  • Or:
  • Creatinine ≥50 ml/min
  • < 1.5 x ULN
  • Normal potassium and magnesium levels.
  • Normal baseline ACTH stimulation test
  • Systolic blood pressure < 160 and diastolic < 95 mmHg documented on at least 3 different occasions. Hypertension currently under control is permitted.
  • Cardiac Ejection Fraction > or = 50% measured by MUGA scan / ECHO
  • Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.

Who cannot join

  • Anti-cancer therapy including radiotherapy (except for palliative reasons), any endocrine therapy, immunotherapy, chemotherapy, or use of other investigational agents within four weeks prior to trial entry (six weeks for nitrosoureas and Mitomycin-C).
  • ER-and AR- breast cancer by immunohistochemistry.
  • Persistent grade 2 or greater toxicities from any cause (Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator and the Drug Development Office (DDO) should not exclude the patient.).
  • Patients with known Central Nervous System (CNS) disease (primary or secondary) or leptomeningeal disease because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
  • Gastrointestinal disorders interfering with absorption of the study drug.
  • Difficulties with swallowing study capsules/tablets.
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  • Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism.
  • History of thromboembolic disease within 12 months of commencing this trial.
  • Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.
  • Major thoracic and/or abdominal surgery or significant traumatic injury within 4 weeks prior to trial entry from which the patient has not recovered.
  • At high medical risk because of non-malignant systemic disease including active infection or serious concurrent illness.
  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy during protocol treatment.
  • Known immunocompromised patients, e.g. Human Immunodeficiency Virus (HIV).
  • Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.
  • Significant cardiovascular disease as defined by:
  • Congestive heart failure with severity NYHA III or IV (see Appendix 4);
  • History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry;
  • Presence of severe valvular heart disease;
  • Presence of a ventricular arrhythmia requiring treatment.
  • Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • University of Birmingham,

    Birmingham, B15 2TT

  • Western General Hospital

    Edinburgh, EH4 2XU

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Guy's Hospital

    London, England, SE1 9RT

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Velindre Cancer Centre

    Whitchurch, Cardiff, CF14 2TL

Other trials in United Kingdom

About this study

Official title: A Cancer Research UK Phase I/II Open Label Study to Evaluate the Safety, Endocrine Effects and Anti-tumour Activity of Abiraterone Acetate (CB7630) in Patients With Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma

RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone acetate and to see how well it works in treating postmenopausal women with advanced or metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the safety and tolerability of abiraterone acetate in postmenopausal women with estrogen receptor- or androgen receptor-positive advanced or metastatic breast cancer. (Phase I)
  • To determine the recommended phase II dose of this drug in these patients. (Phase I)
  • To evaluate the clinical benefit rate of this drug at 24 weeks in these patients. (Phase II)

Secondary

  • To study the pharmacokinetics of this drug in these patients. (Phase I)
  • To determine the endocrine impact of this drug on the pituitary-adrenal-gonad endocrine axis. (Phase I)
  • To estimate the duration of objective tumor response in these patients. (Phase II)
  • To correlate response rates and duration of response with the endocrine profile in these patients. (Phase II)
  • To determine overall survival of these patients. (Phase II)

Tertiary

  • To enumerate and molecularly characterize circulating tumor cells.
  • To identify normal genetic variations that predict resistance to this drug using pharmacogenomic analysis.

OUTLINE: This is a multicenter, phase I study followed by a phase II study. Patients enrolled in the phase II portion of the study are stratified according to hormone receptor status (estrogen receptor [ER]-positive and any androgen receptor [AR] status vs AR-positive and ER-negative).

Patients receive oral abiraterone acetate once daily on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically and analyzed for pharmacokinetic assays (phase I only), pharmacodynamic assays, circulating tumor cells, and pharmacogenomic analysis.

After completion of study treatment, patients are followed for 28 days.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Conditions
Breast Cancer
Being tested
abiraterone acetate, laboratory biomarker analysis, pharmacogenomic studies
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive 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.

  • abiraterone acetateDrug

  • laboratory biomarker analysisOther

  • pharmacogenomic studiesOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Causality of each adverse event and grading severity as measured by NCI CTCAE v3.0 (Phase I)

  2. Maximum tolerated dose (MTD) of abiraterone acetate (Phase I)

  3. Proportion of patients with stable disease for ≥ 24 weeks or objective response as measured by RECIST criteria (Phase II)

Secondary outcomes (5)

  1. Plasma levels of abiraterone acetate as measured by liquid chromatography/tandem mass spectrometry assay (Phase I)

  2. Relationship between dose and endocrine response (Phase I)

  3. Duration of objective tumor response as measured by RECIST criteria (Phase II)

  4. Relationship between tumor response and endocrine response (Phase II)

  5. Median overall survival (Phase II)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completion4 Jun 2016
  4. Study completion4 Jun 2016

Resources

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
Non-randomised
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00755885
Sponsor's protocol ID
CDR0000614059
Other IDs
CRUK-CR9304-21, EUDRACT-2007-003240-30
Status last verified
Jan 2017
First submitted
18 Sep 2008
Last updated
26 Jan 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing abiraterone acetate, laboratory biomarker analysis and pharmacogenomic studies in people with Breast Cancer, run by Cancer Research UK at 6 sites in United Kingdom.

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 25 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. 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?

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?

Causality of each adverse event and grading severity as measured by NCI CTCAE v3.0 (Phase I). The study lists 3 primary outcomes in all. 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 NCT00755885.

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 26 Jan 2017.

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