AzTrials
AzTrials

Carcinoma Breast Stage IVPhase 2NCT02140437

Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC

A Phase 2 study testing Fulvestrant and Anastrozole in people with Carcinoma Breast Stage IV, run by Fudan University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This research is designed to investigate whether the addition of fulvestrant 500mg to anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Carcinoma Breast Stage IV
What is being tested?
Fulvestrant and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2014to Jun 2016
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Histologically confirmed breast cancer
  • Luminal A-like breast cancer (primary or metastatic tumor), defined as: ER-positive, PR-positive (> 20%), Her-2 negative and Ki67 <14%.
  • Advanced breast cancer is eligible:
  • Endocrine therapy-naive patients with locally advanced disease, who are not suitable for radical surgery or radiotherapy (the decision made by the multidisciplinary breast cancer team). Prior first-line cytotoxic chemotherapy is acceptable. or
  • Patients with recurrent or metastatic disease, who have not received adjuvant endocrine therapy or who have been 2 years or longer after stop of adjuvant endocrine therapy. Patients who had disease progression from first-line cytotoxic chemotherapy are allowed.
Show all 16Show fewer
  • At least one lesion (measurable and / or non-measurable) can be assessed at baseline, and is suitable for repeated assessments with CT and/or MRI.
  • Postmenopausal women, defined as any one of the following criteria (as defined in the NCCN's menopause definition):
  • previous bilateral oophorectomy
  • 60 years old or older
  • less than 60 years old, amenorrheic for 12 months or longer in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone and estradiol in the postmenopausal range.
  • If taking tamoxifen, or toremifene and age < 60, then FSH and E in the postmenopausal range
  • ECOG 0, 1 or 2.
  • Patients with good compliance.
  • Must be able to swallow tablets.
  • Without any significant gastrointestinal obstruction or dysfunction of absorption for oral drug.

Who cannot join

  • Life-threatening metastatic visceral disease, defined as extensive liver involvement or any degree of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymphatic metastasis. If the investigator believe that their respiratory function is not significantly impaired due to illness, patients with scattered parenchymal metastases are qualified.
  • Have received any systemic treatment other than first-line cytotoxic chemotherapy.
  • Radiation therapy within 28 days prior to randomization (exception: radiotherapy to control bone pain, but should be completed before the randomization).
  • Use any other anti-cancer therapy at the same time (except bisphosphonate).
  • Previous endocrine treatment for advanced breast cancer.
  • Current or previous malignancy ( except for breast cancer, basal cell or squamous cell carcinoma of the skin with adequate treatment, cervical carcinoma in situ).
Show all 11Show fewer
  • Inadequate blood or liver or renal function within one week prior to randomization: Platelets < 80 × 10^9/L; Total bilirubin > 1.5 × (ULRR) (patients with Gilbert's syndrome is eligible); or ALT or AST > 2.5 × ULRR (without liver metastases) or > 5 × ULRR (with liver metastases).
  • History with hemorrhagic constitution (e.g. disseminated intravascular coagulation, clotting factor deficiency) or long-term anticoagulant therapy.
  • Hypersensitivity history to excipients or castor oil of fulvestrant or anastrozole.
  • Any other severe co-existing medical disorders, ie uncontrolled heart disease.
  • Participation in any clinical trial and / or exposure to any investigational medication within 28 days before randomization.

About this study

Official title: An Open-label, Multi-center, Randomized Phase II Study of Fulvestrant Anastrozole Combination Versus Anastrozole Alone in Patients With Luminal A-like Postmenopausal Advanced Breast Cancer

This research is designed to investigate whether the addition of fulvestrant 500mg to anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced breast cancer.

Read the detailed description

Anastrozole is the standard first-line endocrine treatment for patients with hormonal receptor positive advanced breast cancer. It has been proven that the addition of fulvestrant 250mg can enhance PFS of anastrozole monotherapy according to SWOG0226 study. However, the optimal recommended dose of fulvestrant for patients with advanced breast cancer is 500mg worldwide according to CONFIRM study. The investigator designed this research to investigate whether high dose fulvestrant can further improve efficacy of anastrozole monotherapy.

Keywords
Fulvestrant, Anastrozole, Luminal A-like, Postmenopausal, Advanced 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.

  • FulvestrantDrug

    Also called falsodex

    Adding fulvestrant to the standard endocrine therapy, anastrozole

  • AnastrozoleDrug

    Also called Arimidex

    standard endocrine therapy

Study groups in NCT02140437
Study groupRoleWhat they receive
Fulvestrant and anastrozoleExperimentalAnastrozole 1 mg PO QD Fulvestrant 500mg IM d1,15, 29 and 4 weeks after
Receives: Drug: Fulvestrant; Drug: Anastrozole
AnastrozoleActive comparatorAnastrozole 1 mg PO QD
Receives: Drug: Anastrozole

What is being measured

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

  1. PFS(Progression free survival)

    Measured: 8 weeks

Secondary outcomes (1)

  1. OS(overall survival )

    Measured: 8 weeks

Timeline

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

  1. First posted16 May 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Why it stopped: The progress of enrollment is too slow.

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
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140437
Sponsor's protocol ID
Fudan BR2014-14
Status last verified
Dec 2015
First submitted
9 May 2014
Last updated
29 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulvestrant and Anastrozole in people with Carcinoma Breast Stage IV, run by Fudan University.

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 16 inclusion and 11 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: withdrawn, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

PFS(Progression free survival) (time frame: 8 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 NCT02140437.

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 29 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in