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Breast CancerPhase 3NCT01352091

Adjuvant AI Combined With Zoladex

A Phase 3 study testing Zoladex+AI and TAM in people with Breast Cancer, run by Fudan University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Zoladex+AI and TAM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
670 participants
Where
1 siteChina
Study dates
May 2008to Apr 2018
Phase
Phase 3
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

  • All patients must have signed and dated an informed consent form
  • Patients must be female
  • Primary invasive breast cancer pathologically approved by core needle or open biopsy
  • Ipsilateral axillary or internal mammary nodes positive, or tumor size is equal to or larger than 4cm. Definition of nodes positive is according to the staging system of AJCC 6th edition (American Joint Cancer Commission) for breast carcinoma. The micrometastasis must be at least 0.2mm
  • Patients must have undergone standard surgery for primary breast cancer as shown in the following:
  • a standard radical mastectomy or modified mastectomy
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  • standard breast conservation surgery (BCS), which is lumpectomy or qaudrantectomy accompany with axillary dissection, and the surgical margins of the resected specimen must be negative. BCS must be followed by standardized adjuvant radiotherapy to the partial conserved breast (delivered after adjuvant chemotherapy completed)
  • Treatment for confirmed breast cancer including the surgery modality listed above, loco-regional radiotherapy after lumpectomy, adjuvant radiotherapy to the chest wall and/or internal mammary nodes and/or supraclavicular lymph nodes, adjuvant chemotherapy
  • adjuvant endocrine therapy of TAM or Fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished
  • The date of randomization must be processed after taking TAM or Fareston for 2 or more than 2 years, but not more than 3 years of time
  • Patients taking neo-chemotherapy are eligible, and lymph node status could be identified during surgery before neo-adjuvant chemotherapy or after neo-adjuvant chemotherapy. The definition of lymph node positive is:
  • evaluation of lymph node status before neo-adjuvant chemotherapy must include pathological axillary nodes, internal mammary nodes (pN2b option) or supraclavicular nodes (pN3c option) involved. Micro-metastasis (i.e.≥0.2mm, pN1-pN3c) can be identified by the following method: fine needle aspiration (FNA) or sentinel node biopsy (SNB) or sampling/ total procedure of axillary dissection
  • patients with no nodes positive after neo-adjuvant chemotherapy, lymph node positive must be evaluated during surgery. Its definition was the either of following:
  • According the clinical practice guidelines of the local cancer center, it is acceptable when positive nodes was identified by SNB or axillary dissection
  • There is pathological evidence in lymph nodes positive (pN1-pN3c) during breast surgery after neo-adjuvant chemotherapy
  • Patients diagnosed as occult breast cancer clinically are found to pathologically have primary invasive carcinoma or DCIS with micro-invasive lesion in ipsilateral breast, and primary lesion or axillary node metastasis express ER and/or PR positive
  • Patients with synchronous bilateral cancers are eligible on the condition that If one side is IDC and the other side is DCIS, the IDC side should be of the ER and/or PR positive phenotype and IF two sides are both IDC, they must be ER and/or PR positive phenotype at the same time
  • Hormone receptor positive (≥＋) is defined as detecting ER or PR expression at any time is eligible. The situation of only PR positive and ER negative is eligible, too
  • According to the standard operation principles for clinical practice of local cancer center, patients must be randomized within 4 weeks after definitive physical examination, imaging examination and laboratory testing show no evidence of recurrence or metastasis
  • Based on the study objective, all patients are required to be premenopausal as defined by
  • menstruating actively
  • less than 6 months since last menstrual period (LMP), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free E2、FSH and LH level was premenopausal (according to the reference value of local center).
  • had previous hysterectomy with one or both ovaries left intact are eligible if the serum free E2、FSH and LH level are premenopausal (according to the reference value of local center).
  • patients must have an ECOG performance status of 0 or 1 (0-fully active, able to carry on all pre-disease performance without restriction, 1-restricted in physical strenuous actively but ambulatory)
  • leucocyte count must be ≥3.0*10^9/L and platelet count must be ≥100*10^9/L
  • AST/SGOT or ALT/AGPT must be <3 times the ULN
  • serum creatinine must be <2 times the ULN
  • patients can swallow pills
  • pregnancy testing is negative and are willing to do contraception during the treatment period

Who cannot join

  • patients with metastatic malignant tumor
  • previous history of asynchronous bilateral breast cancer
  • any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin
  • any non-malignant systemic disease which interfere long time follow up
  • history of medical ovarian ablation therapy
  • history of AI therapy
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  • severe live dysfunction, Child-Pugh is grade C
  • Occult breast cancer is found pathologically no IDC lesion or only DCIS without micro-invasive lesion in the ipsilateral breast
  • patients with Her-2 overexpression had used, or is using, or intending to use adjuvant trastuzumab
  • severe heart dysfunction, heart functional classification is above Class III Table 2 Child-Pugh score of hepatic cirrhosis

Trial locations and contacts

1 site in 1 country.

Zhi-min Shao, MD contact

86-021-64175590 ext. 8808

zhimingshao@yahoo.com

Ya-jie Ji, MD contact

86-13818942254

jing_hong2008@yahoo.com.cn

China1 site, 1 recruiting

  • FUSCC

    Shanghai, Shanghai Municipality, 200032

    Zhi-min Shao, MD, 86-021-64175590 ext. 8808, zhimingshao@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized ,Open Label Study Comparing the Efficacy of Zoladex® Combined With Arimidex® for 3-2 Years After Selective Estrogen Receptor Modulators (SERMs) as an Adjuvant Therapy for 2-3 Years Versus Continuing Tamoxifen up to 5 Years for Premenopausal Early Breast Cancer Patients With Hormone Receptor Positive, Lymph Node Positive or Tumor≥ 4cm.

The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive, lymph node positive or tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative. The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination. Based on the operating standard of local medical institution, identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately.

Conditions
Breast Cancer
Being tested
Zoladex+AI, TAM
Keywords
breast cancer, adjuvant endocrine therapy, AI, Zoladex
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Zoladex+AIDrug

    Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years

  • TAMDrug

    Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.

Study groups in NCT01352091
Study groupRoleWhat they receive
Switch to Zoladex + AI for 3-2 yearsExperimentalPatients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years
Receives: Drug: Zoladex+AI
TAMExperimentalPatients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.
Receives: Drug: TAM

What is being measured

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

  1. DFS

    Disease free survival (DFS): DFS related events ware defined as local recurrence, distant metastasis, secondary primary cancer or death, whichever occurred first.during follow up

    Measured: 5 Years

Secondary outcomes (6)

  1. OS

    Overall survival (OS)

    Measured: 5 years

  2. Time to distant metastasis

    Time to distant metastasis

    Measured: 5 years

  3. Bilateral secondary primary breast cancer morbidity

    Bilateral secondary primary breast cancer morbidity

    Measured: 5 years

  4. DDFS

    Distant disease free survival (DDFS)

    Measured: 5 years

  5. Osteoporosis related events

    Osteoporosis related events ( BMD and bone fracture incidence)

    Measured: 5 years

  6. Other adverse events

    Other adverse events (Gynecological events, blood lipids, thrombosis, cardiovascular diseases, and etc.)

    Measured: 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 posted11 May 2011 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2015 (estimated)
  4. Study completionApr 2018 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
670 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352091
Sponsor's protocol ID
CBCSG002
Status last verified
Apr 2008
First submitted
10 May 2011
Last updated
11 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Li JW, Liu GY, Ji YJ, Yan X, Pang D, Jiang ZF, Chen DD, Zhang B, Xu BH, Shao ZM. Switching to anastrozole plus goserelin vs continued tamoxifen for adjuvant therapy of premenopausal early-stage breast cancer: preliminary results from a randomized trial. Cancer Manag Res. 2018 Dec 27;11:299-307. doi: 10.2147/CMAR.S183672. eCollection 2019.

    PubMed 30643455

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoladex+AI and TAM in people with Breast Cancer, run by Fudan University at 1 site 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 29 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 11 May 2011. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Zhi-min Shao, MD (86-021-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: 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 NCT01352091, 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 11 May 2011.

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Adjuvant AI Combined With Zoladex (NCT01352091) | AzTrials