AzTrials
AzTrials

Breast CancerNCT01425294

Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

An observational study of Breast Cancer, run by AstraZeneca at 23 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer
How many people
231 participants
Where
23 sitesChina
Study dates
1 Aug 2011to 30 Jan 2016
Phase
Observational
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Medical units

Who may be able to join

  • Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
  • The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
  • Provision of subject informed consent.

Who cannot join

  • If participating in any controlled clinical trial, the subject cannot take part in this study.
  • Hypersensitivity to the active substance, or to any of the other excipients.
  • Pregnancy and lactation, or severe hepatic impairment.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Research Site

    Beijing, Beijing Municipality

  • Research Site

    Changchun, Jilin

  • Research Site

    Changsha, Hunan

  • Research Site

    Chengdu, Sichuan

  • Research Site

    Fuzhou, Fujian

  • Research Site

    Guangzhou, Guangdong

  • Research Site

    Guiyang, Guizhou

  • Research Site

    Hanghzou, Zhejiang

  • Research Site

    Hangzhou, Zhejiang

  • Research Site

    Harbin, Heilongjiang

  • Research Site

    Hohhot, Inner Mongolia

  • Research Site

    Kunming, Yunnan

  • Research Site

    Kunshan, Jiangsu

  • Research Site

    Nanjing, Jiangsu

  • Research Site

    Nantong, Jiangsu

  • Research Site

    Qingdao, Shandong

  • Research Site

    Shanghai, Shanghai Municipality

  • Research Site

    Tangshan, Hebei

  • Research Site

    Tianjin, Tianjin Municipality

  • Research Site

    Weifang, Shandong

  • Research Site

    Wuhan, Hubei

  • Research Site

    Xuzhou, Jiangsu

  • Research Site

    Zhoushan, Zhejiang

Other trials in China

About this study

Official title: A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice

This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

Read the detailed description

A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice

Conditions
Breast Cancer
Keywords
Chinese post-menopausal women, oestrogen receptor-positive locally advanced, metastatic breast cancer, fulvestrant 250 mg, failure to adjuvant anti-oestrogen therapy
Medical subject headings
Breast Neoplasms

What is being measured

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

  1. To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

    The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

    Measured: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Secondary outcomes (3)

  1. Objective response rate (ORR)

    ORR was defined as the percentage of patients who had a best objective tumour response of either complete response (CR) or partial response (PR) among the evaluable patients with measurable disease at baseline. The best overall response was the best response recorded from the start of the treatment until disease progression. The RECIST1.1 criteria were used to assess objective tumour response. ORR was summarized and expressed as the percentage together with the corresponding 95% confidence intervals (CI).

    Measured: Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.

  2. Frequency of Adverse Events

    Adverse events (AEs) data were coded using Medical dictionary for Regulatory Activities (MedDRA) version 14.0 and summarized by preferred term (PT) and system organ class (SOC).

    Measured: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

  3. Severity of Adverse Events

    SAEs causally related to study drug, AEs leading to discontinuation, AEs leading to death, respectively. Separate listings were provided for AEs causally related to study drug, AEs leading to death, respectively. The severity of all adverse events was analyzed according to CTCAE grading.

    Measured: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Timeline

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

  1. First posted30 Aug 2011 (estimated)
  2. Study start1 Aug 2011
  3. Primary completion30 Jan 2016
  4. Study completion30 Jan 2016

Why it stopped: The study has been decided to be early terminated for the FAS 500 mg has launched in 2015. The use mothod of 250mg per month in clinical practice is off-label.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425294
Sponsor's protocol ID
NIS-OCN-FAS-2011/1
Status last verified
Dec 2017
First submitted
19 Aug 2011
Last updated
5 Dec 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269

  • Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.

    PubMed 1855205

  • Kansra S, Yamagata S, Sneade L, Foster L, Ben-Jonathan N. Differential effects of estrogen receptor antagonists on pituitary lactotroph proliferation and prolactin release. Mol Cell Endocrinol. 2005 Jul 15;239(1-2):27-36. doi: 10.1016/j.mce.2005.04.008.

    PubMed 15950373

  • Beverage JN, Sissung TM, Sion AM, Danesi R, Figg WD. CYP2D6 polymorphisms and the impact on tamoxifen therapy. J Pharm Sci. 2007 Sep;96(9):2224-31. doi: 10.1002/jps.20892.

    PubMed 17518364

  • Gallo MA, Kaufman D. Antagonistic and agonistic effects of tamoxifen: significance in human cancer. Semin Oncol. 1997 Feb;24(1 Suppl 1):S1-71-S1-80.

    PubMed 9045319

  • Osborne CK, Coronado-Heinsohn EB, Hilsenbeck SG, McCue BL, Wakeling AE, McClelland RA, Manning DL, Nicholson RI. Comparison of the effects of a pure steroidal antiestrogen with those of tamoxifen in a model of human breast cancer. J Natl Cancer Inst. 1995 May 17;87(10):746-50. doi: 10.1093/jnci/87.10.746.

    PubMed 7563152

  • Howell A, DeFriend D, Robertson J, Blamey R, Walton P. Response to a specific antioestrogen (ICI 182780) in tamoxifen-resistant breast cancer. Lancet. 1995 Jan 7;345(8941):29-30. doi: 10.1016/s0140-6736(95)91156-1.

    PubMed 7799704

  • Howell A, DeFriend DJ, Robertson JF, Blamey RW, Anderson L, Anderson E, Sutcliffe FA, Walton P. Pharmacokinetics, pharmacological and anti-tumour effects of the specific anti-oestrogen ICI 182780 in women with advanced breast cancer. Br J Cancer. 1996 Jul;74(2):300-8. doi: 10.1038/bjc.1996.357.

    PubMed 8688341

  • Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, Vergote I, Erikstein B, Webster A, Morris C. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002 Aug 15;20(16):3396-403. doi: 10.1200/JCO.2002.10.057.

    PubMed 12177099

  • Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, Webster A, Morris C, Elledge R, Buzdar A. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002 Aug 15;20(16):3386-95. doi: 10.1200/JCO.2002.10.058.

    PubMed 12177098

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by AstraZeneca at 23 sites in China.

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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. 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.

Are results available for this study?

The study was stopped early (reason given: The study has been decided to be early terminated for the FAS 500 mg has launched in 2015. The use mothod of 250mg per month in clinical practice is off-label.). 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?

To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice. (time frame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.). 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 NCT01425294, which also lists 10 linked publications.

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 5 Dec 2017.

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