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Breast NeoplasmsPhase 4NCT01176916

Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China

A Phase 4 study testing Aromasin (exemestane) in people with Breast Neoplasms, run by Pfizer at 53 sites in China.

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

Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen \& are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Aromasin (exemestane)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
53 sitesChina
Study dates
9 Feb 2011to 30 Nov 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
  • ER positive.
  • The patient must be postmenopausal woman.
  • The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).

Who cannot join

  • Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.
  • Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

China53 sites

  • Cancer Hospital Chinese Academy of medical sciences

    Beijing, 100021

  • Fifth Medical Center of the PLA General Hospital

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital/Department of Oncology

    Beijing, 100191

  • China-Japan Friendship Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department

    Bengbu, Anhui, 233004

  • The first hospital of jilin university

    Changchun, Jilin, 130021

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • Xiangya Hospital Central South University /Department of Breast

    Changsha, Hunan, 410008

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213004

  • West China Hospital, Sichuan University/ Oncology Department

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Breast Surgery of The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • SUN YAT-SEN Memorial Hospital , SUN YAT-SEN University

    Guangzhou, Guangdong, 510260

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Second Affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The Affiliated Hospital of inner Mongolia medical university

    Hohhot, Inner Mongolia, 010021

  • Jingzhou Hospital Tongji Medical College Huazhong university of science and Technology

    Jingzhou, Hubei, 434020

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • The First hospital of LanZhou university

    Lanzhou, Gansu, 730000

  • Linyi People's Hospital

    Linyi, Shandong, 276000

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Jiangsu Cancer Hospital/ Surgery Department

    Nanjing, Jiangsu, 210000

  • Jinling Hospital

    Nanjing, Jiangsu, 210002

  • Jiangsu Province Hospital/ Surgery Department

    Nanjing, Jiangsu, 210029

  • Nanjing Maternity and Child Health Care Hospital/Department of Breast Surgery

    Nanjing, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266061

  • Qingdao municipal Hospital

    Qingdao, Shandong, 266072

  • Fudan University Shanghai Cancer center/Department of Breast Surgery

    Shanghai, 200032

  • Yangpu District Central Hospital

    Shanghai, 200090

  • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

    Shanghai, 200092

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • The Fourth Affiliated Hospital Of China Medical University

    Shenyang, Liaoning, 110032

  • Thyroid and breast surgery

    Shenzhen, Guangdong, 518035

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215002

  • Tianjin Cancer Hospital/Breast cancer department

    Tianjin, Tianjin Municipality, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Breast Surgery of The Weifang People's Hospital

    Weifang, Shandong, 261041

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan, 453100

  • Breast and thyroid surgery of the Central Hospital of WuHan

    Wuhan, Hubei, 430014

  • The First Affiliated Hospital of The Fourth Military Medical University

    Xi'an, Shaanxi, 710032

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Breast Surgery of YanTai Yu Huang Ding Hospital

    Yantai, Shandong, 264000

  • Affiliated hospital of Guangdong medical college

    Zhanjiang, Guangdong, 524001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • Henan provincial people's hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

  • Breast and thyroid surgery of Central Hospital of Zibo

    Zibo, Shandong, 255036

Other trials in China

About this study

Official title: A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN

Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen \& are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

Read the detailed description

This is interventional study and single arm study. N/A

Being tested
Aromasin (exemestane)
Keywords
breast cancer, Aromasin, adjuvant chemotherapy, endocrine therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Aromasin (exemestane)Drug

    the dosage, frequency and duration base on the LPD approved by SFDA.

Study groups in NCT01176916
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Aromasin (exemestane)

What is being measured

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

  1. Time-to-Event

    An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Secondary outcomes (6)

  1. Percentage of Participants Experiencing Each Event

    An event was defined as the following: 1) Loco-regional/distant recurrence of the primary breast cancer (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

  2. Incidence Rate of Each Event

    Incidence rate (per annum) of the event was defined as a ratio of the number of events and the total exposure time (in years) to Aromasin therapy.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

  3. Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event

    A Cox proportional hazards regression model was used to evaluate the relationship between HER2 status level (binary) and time-to-event (Positive vs Negative). The method for selecting factors for the Cox regression model was based on significant results at univariate analysis and the clinical judgement for the multivariate model. Stepwise method was used for the selection of final independent variables. The criteria for stepwise selection were pentry = 0.25 and pstay = 0.15.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

  4. Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event

    A Cox proportional hazards regression model with stepwise selection was used to evaluate the influence of multiple disease variables on the time-to-event. The disease variables in the initial model included Eastern Cooperative Oncology Group [ECOG] performance status at diagnosis; and Tumor, Lymph Node and Metastasis [TNM] stage at initial diagnosis. The ECOG Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. ECOG performance status at diagnosis level included 0, 1, 2, 3 and 4, with Level 0 as the best status and Level 4 as the worst. The TNM system helps describe the size of cancer tumor and the extent to which it spreads to nearby tissues/distant parts of the body. TNM stage at initial diagnosis level included 1 (Stage I), 2 (Stage IIA), 3 (Stage IIB), 4 (Stage IIIA), 5 (Stage IIIB) and 6 (Stage IIIC), with Level 1 as the best status and Level 6 as the worst.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

  5. Number of Participants With Discontinuation Due to Adverse Events (AEs)

    Participants permanently discontinued from the study due to AEs were counted for this outcome measure. An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The number of participants with discontinuation due to all-causality and treatment-related AEs are reported below. Treatment-related AEs were determined by the investigator.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    All-causality TEAEs were counted for this outcome measure. TEAE is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. The number of participants with all-causality and treatment-related TEAEs are reported below. Treatment-related TEAEs were determined by the investigator.

    Measured: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)

Timeline

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

  1. First posted6 Aug 2010 (estimated)
  2. Study start9 Feb 2011
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

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 4
Masking
None (open label)
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01176916
Sponsor's protocol ID
A5991093
Other IDs
NRA5990043
Status last verified
Oct 2021
First submitted
4 Aug 2010
Last updated
27 Oct 2021
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aromasin (exemestane) in people with Breast Neoplasms, run by Pfizer at 53 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 4 inclusion and 2 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time-to-Event (time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)). 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 NCT01176916.

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 27 Oct 2021.

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