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Stage IA Breast CancerPhase 2NCT01800422

Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer

A Phase 2 study testing telapristone acetate, therapeutic conventional surgery and laboratory biomarker analysis in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Northwestern University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication that works against the hormone, progesterone. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
telapristone acetate, therapeutic conventional surgery and laboratory biomarker analysis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
Jun 2013to Mar 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

  • Subjects must be females with a histological diagnosis of invasive breast cancer clinical stage T1-2, N01 and be candidates for primary resection of this cancer; note: subjects with bilateral cancer are eligible
  • Primary tumor stage T1-2 at the time of initial diagnosis and ipsilateral nodes must be N0-1 by clinical evaluation. Staging is routinely based on the NCCN Clinical Practice Guidelines and TNM Nomenclature for Breast Cancer from AJCC Cancer Staging Manual. All breast cancer patients routinely undergo axillary ultrasound to evaluate nodal involvement.
  • Subjects must have greater than 0.5 cm of IBC on core (5 cores).
  • Subjects must be age > or = 18 years.
  • Subjects must exhibit an ECOG performance status of 0 or 1.
  • Subjects must be able and willing to schedule surgical resection of their tumor 2 or more weeks following the start of the study agent.
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  • Subjects must have adequate hepatic and renal function, within 6 weeks prior to registration. The liver function tests include total bilirubin (<1.5xULN; Gilbert"s allowed 3x ULN), ALT/ AST (<2.5xULN) and alkaline phosphatase(<2.5xULN); the standard renal function tests include blood urea nitrogen (BUN), and creatinine and must be < 2XULN.
  • Subjects of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; OR
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Subjects of child bearing potential must have a negative urine pregnancy test within 5 days prior to first dose of the study drug.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent. Informed consent must be obtained prior to registration on the study

Who cannot join

  • Subjects must not have a breast cancer diagnosis of ductal carcinoma in situ only (DCIS)
  • Subjects must not have received any other breast cancer-specific therapy prior to registration
  • Subjects must not have received any oral contraceptive or postmenopausal hormones within one month prior to their diagnostic biopsy AND must agree not to use exogenous sex hormones while on the study
  • Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
  • Subjects must not have a history of thromboembolic disorder or cerebral vascular disease
  • Subjects must not have a body mass index (BMI) > 39
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  • Subjects must not be pregnant or nursing
  • Subjects must not be receiving any other investigational agents
  • Subjects must not have allergies to any compounds similar to CDB-4124
  • While participating, subjects must agree not to use soy supplements, over the counter estrogen supplements like Estroven, Chinese herbs, or other over-the-counter (OTC) herbal products

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women With Stage I-II Primary Breast Cancer

The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication that works against the hormone, progesterone. The researchers in this study would like to compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to those from women who have taken a placebo pill prior to surgery.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To test the hypothesis that treatment with the selective progesterone receptor modulator (SPRM) CDB-4124 (telapristone acetate) will have an anti-tumor effect in women with early-stage breast cancer, defined as a significant decrease in tumor proliferation (Ki67 labeling index).

SECONDARY OBJECTIVES:

  1. Measure changes in apoptosis using IHC (cleaved caspase 3 or TUNEL). II. Measure changes in blood estradiol and progesterone levels. III. Compare the breast tissue concentrations of CDB-4124 and its metabolite (CDB4453) to plasma concentrations at the end of therapy.

IV. Assess adverse events.

TERTIARY OBJECTIVES:

  1. Measure protein expression of related targets (including estrogen receptor alpha (ERA), estrogen receptor beta (ERB), progesterone receptor isoforms progesterone receptor alpha [PRA], progesterone receptor beta [PRB], tumor necrosis factor receptor superfamily, member 11a, NFKB activator [RANK], tumor necrosis factor (ligand) superfamily, member 11 [RANKL], and either cyclin-dependent kinase 2 [cdk2] or cyclin-dependent kinase 4 [cdk4],) using IHC at baseline and after treatment.

II. Perform ribonucleic acid (RNA) microarray analysis comparing tumors and normal tissue from the intervention and control groups.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive telapristone acetate orally (PO) once daily (QD) for 2-10 weeks and then undergo surgical resection.

ARM II: Patients receive placebo orally once daily for 2-10 weeks and then undergo surgical resection.

After completion of study treatment, patients are followed up for 1 month.

Being tested
telapristone acetate, placebo, therapeutic conventional surgery, laboratory biomarker analysis, questionnaire administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telapristone acetateDrug

    Also called CDB-4124, Proellex, Progenta, progesterone receptor inhibitor CDB-4124

    Given orally

  • placeboOther

    Also called PLCB

    Given orally

  • therapeutic conventional surgeryProcedure or surgery

    Undergo surgical resection

  • laboratory biomarker analysisOther

    Correlative studies

  • questionnaire administrationOther

    Ancillary studies

Study groups in NCT01800422
Study groupRoleWhat they receive
Arm I (telapristone acetate)ExperimentalPatients receive telapristone acetate orally once daily for 2-10 weeks and then undergo surgical resection.
Receives: Drug: telapristone acetate; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: questionnaire administration
Arm II (placebo)Placebo comparatorPatients receive placebo orally once daily for 2-10 weeks and then undergo surgical resection.
Receives: Other: placebo; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: questionnaire administration

What is being measured

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

  1. Measurable decrease in tumor growth from baseline to time of surgery

    Treatment efficacy will be assessed by comparing tissue samples from the baseline biopsy and tissue samples collected from the day of surgery to measure if there is a decrease in tumor growth.

    Measured: Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)

Secondary outcomes (4)

  1. Compare changes in expression of apoptosis marker at the time of surgery

    Using tissue samples, the expression of apoptosis marker will be measured in the intervention group and compared to the placebo group at the time of surgery.

    Measured: At time of surgery (between 2-10 weeks, up to 10 weeks)

  2. Measure changes in blood estradiol and progesterone levels

    Serum estradiol and progesterone levels will be measured at baseline and at the time of surgery to assess any changes.

    Measured: Baseline to time of surgery (between 2-10 weeks, up to 10 weeks)

  3. Compare breast tissue concentrations of study drug and its metabolite (CDB4453) to plasma concentrations at the end of treatment

    Breast tissue concentrations of study drug will be measured in tumor and normal tissue adjacent to the tumor at the time of surgery. Plasma concentrations of drug will also be measured for comparison to see if there is a correlation between tissue concentration of drug and the reduction in tumor growth after treatment.

    Measured: At the time of surgery (between 2-10 weeks, up to 10 weeks)

  4. Liver and renal function as well as symptom evaluation (via questionnaire) will be analyzed to assess adverse events experienced

    Adverse events will be assessed throughout treatment by evaluating liver and renal function tests that will be performed at baseline, week 4, and at the post-intervention (pre-surgical) visit. Symptom measurements (using a questionnaire) will be performed at baseline, post-intervention (pre-surgical), and 1 month following surgery.

    Measured: At baseline and every 2 weeks while on treatment, day of surgery (between 2-10 weeks, up to 10 weeks), and 1 month following surgery

Timeline

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

  1. First posted27 Feb 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2021 (estimated)
  4. Study completionMar 2022 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800422
Sponsor's protocol ID
NU 12B09
Other IDs
NCI-2012-03189, STU00074599
Status last verified
Jan 2020
First submitted
24 Feb 2013
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing telapristone acetate, therapeutic conventional surgery and laboratory biomarker analysis in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by Northwestern University at 1 site in United States.

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 10 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Measurable decrease in tumor growth from baseline to time of surgery (time frame: Baseline to time of surgery (between 2-10 weeks, up to 10 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 NCT01800422.

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 18 Jan 2020.

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