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Breast CancerPhase 2NCT01613560

Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy

A Phase 2 study testing AI adjuvant therapy and AI+chemotherapy adjuvant therapy in people with Breast Cancer, run by Tao OUYANG at 14 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study. The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis… Read more about this study

Who is it for?
Ages Up to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
AI adjuvant therapy and AI+chemotherapy adjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
14 sitesChina
Study dates
5 May 2012to Dec 2024
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 Up to 75 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Female, not more than 75 years old, judged to have been in menopause by the investigator when enrolled. Refer to the following criteria to determine whether they are postmenopausal breast cancer.
  • Spontaneous amenorrhea for more than 12 months Age ≥ 60 Age < 60, but FSH and E2 reach postmenopausal level.
  • Received bilateral ovariectomy previously
  • Not to define the women using LHRH agonists or antagonists as in postmenopausal state.
  • Evidence of primary invasive breast cancer is confirmed by histopathological diagnosis.
  • Clinical stage is T2-3N0M0
Show all 13Show fewer
  • ER or PgR are expressed in more than 50 percent of tumour cells, and HER2 is negative.
  • No abnormal axillary nodes in ultrasound examination; no evidence of cancer metastasis confirmed by abnormal lymph node puncture pathological examination
  • With plan of receiving simple endocrinotherapy and avoiding adjuvant chemotherapy
  • No previous breast cancer treatment history
  • No other tumors previously; no unstable complications or uncontrolled infection.
  • No contraindication for endocrinotherapy with 3rd generation of aromatase inhibitors
  • Participate in the trial voluntarily and sign the informed consent form.

Who cannot join

  • Evidence of distant breast cancer metastasis by pathological and imaging diagnosis
  • Patients who have a history of other malignant tumors
  • With contraindications for 3rd generation of aromatase inhibitors
  • Physical condition can not bear the experiment
  • Patients who have potential mental, psychological, familial, social, geographic, or other factors that can hinder study regime performance.
  • Patients who were treated or are treated with other anti-tumor measures before or during this trial, or planed to participate in other clinical trials.
  • Patients who refuse to participate in the trial.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Peking Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

  • 301 Hospital of Pla

    Beijing, Beijing Municipality

  • 307 Hospital of Pla

    Beijing, Beijing Municipality

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Cancer Institution and Hospital.Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Second Hospital of Shandong University

    Jinan, Shandong

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study. The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant endocrinotherapy.

Read the detailed description

In the decision-making process of a systemic adjuvant therapy for ER-positive/HER2-negative breast cancer, to avoid adjuvant chemotherapy is an attractive but hard choice. On one hand, the result of tamoxifen endocrine therapy combined with adjuvant chemotherapy is superior to tamoxifen endocrine therapy alone for ER-positive breast cancer patients; on the other hand, the benefit that adjuvant chemotherapy provides to breast cancer with high hormone receptor expression is not clear and the tolerance of chemotherapy is much lower than that of endocrinotherapy.

St. Galen consensus on adjuvant therapy for early breast cancer recommends adopting simple endocrinotherapy and avoiding adjuvant chemotherapy for medium- and low- risk breast cancer with hormone receptor highly expressed. However, the results of study P024 and IMPACT suggest that hormone receptor expression is insufficient to predict the effect of endocrinotherapy.

At present, the proven clinical value of neoadjuvant endocrinotherapy is to assist surgery. Consensus recommends neoadjuvant endocrinotherapy for the patients with postmenopausal breast cancer who plan to receive simple adjuvant endocrinotherapy. The current study results show that neoadjuvant endocrinotherapy may be used as an experimental treatment platform, i.e., it can predict the results of adjuvant endocrinotherapy through comprehensive analysis of multiple indexes of the surgery samples after neoadjuvant endocrinotherapy.

By using P024 and IMPACT samples, Ellis et al studied the relation between survival and the test results of surgery samples after neoadjuvant endocrinotherapy, and obtained PEPI (the preoperative endocrine prognostic index). They have preliminarily proved that the PEPI score is relative to RFS (relapse-free survival) of postmenopausal ER-positive breast cancer treated with simple endocrinotherapy and to BCSS (breast cancer-specific survival).

A retrospective study，performed by breast prevention and treatment center in Peking University Cancer Hospital，shows that RFS in PEPI score ≤ 1 group is superior to the PEPI > 1 group after 16 weeks of neoadjuvant endocrinotherapy(p = 0.037), and RFS in effective group (Miller\&Payne G1G2G3) is better than that in ineffective group (p=0.001) in terms of pathological evaluation.

The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant endocrinotherapy.

Conditions
Breast Cancer
Being tested
AI adjuvant therapy, AI+chemotherapy adjuvant 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.

  • AI adjuvant therapyDrug

    preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years

  • AI+chemotherapy adjuvant therapyDrug

    preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years after adjuvant chemotherapy

  • AI adjuvant therapyDrug

    preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years

Study groups in NCT01613560
Study groupRoleWhat they receive
PEPI：2-4 group-AExperimentalNot described
Receives: Drug: AI+chemotherapy adjuvant therapy
PEPI：2-4 group-BActive comparatorNot described
Receives: Drug: AI adjuvant therapy
PEPI：0-1groupActive comparatorNot described
Receives: Drug: AI adjuvant therapy

What is being measured

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

  1. RFS

    RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer

    Measured: after a follow up of 5 years

  2. DDFS

    DDFS events includes distant metastasis due to breast cancer

    Measured: after a follow up of 5 years

  3. BCSS

    BCSS events includes death for breast cancer

    Measured: after a follow up of 5 years

Secondary outcomes (1)

  1. adverse reaction

    incidence rate of Ⅲ or Ⅳ adverse reaction(according to NCI classification)

    Measured: during the period of trial (up to 7 years)

Timeline

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

  1. First posted7 Jun 2012 (estimated)
  2. Study start5 May 2012
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01613560
Sponsor's protocol ID
BCP08
Status last verified
Nov 2021
First submitted
27 May 2012
Last updated
29 Nov 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang X, Fan Z, Wang X, He Y, Liu Y, Wang X, Zhang B, Jiang Z, Wang T, Yu Z, Wang F, Liu Y, Li Y, Zhang J, Luo B, Jiang H, Wang T, Xie Y, Li J, Ouyang T. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 Oct;195(3):301-310. doi: 10.1007/s10549-022-06686-1. Epub 2022 Aug 2.

    PubMed 35917052

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AI adjuvant therapy and AI+chemotherapy adjuvant therapy in people with Breast Cancer, run by Tao OUYANG at 14 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 13 inclusion and 7 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 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

RFS (time frame: after a follow up of 5 years). 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 NCT01613560, which also lists 1 linked publication.

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 Nov 2021.

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Clinical Trial NCT01613560 | AzTrials