Neoadjuvant TherapyPhase 3ACCNNCT02769104
Aromatase Inhibitors Plus Chemotherapy vs Chemotherapy as Neoadjuvant Treatment in Postmenopausal HR(+) Breast Cancer
A Phase 3 study testing Letrozole (Aromatase Inhibitors) and AC*4-T*4 in people with Neoadjuvant Therapy, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- Letrozole (Aromatase Inhibitors) and AC*4-T*4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2019
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provision of informed consent
- clinical stage IIA~IIIC
- histologically proven HR+ invasive breast cancer
- women defined as postmenopausal according to NCCN guideline
- plan to accept the neoadjuvant (pre operational) chemotherapy treatment
Who cannot join
- clinical evidence of metastatic disease
- bilateral oophorectomy;
- radiation of the ovaries
- patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- patients who accepted anti-cancer treatment before
- previous hormonal therapy as adjuvant treatment for non-cancer disease
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- patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
- previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- treatment with a non-approved or experimental drug during 1 month before entry into the study
- history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
- leukopenia and/or thrombocytopenia
- history of ocular fundus diseases
- history of thromboembolic diseases
- history of osteoporotic fractures
Trial locations and contacts
1 site in 1 country.
Hong-Jian Yang, MD. contact
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Hong-Jian Yang, MD., yhjzlyy@163.com
Hong-Jian Yang, MD.
About this study
Official title: Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.
Read the detailed description
The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.
- Conditions
- Neoadjuvant Therapy
- Being tested
- Letrozole (Aromatase Inhibitors), AC*4-T*4
- Keywords
- aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, 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.
Letrozole (Aromatase Inhibitors)Drug
Also called Letrozole
Letrozole (Aromatase Inhibitors) for 5 years
AC*4-T*4Drug
Also called CTX+Anthracyclines, Docetaxel
CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles
| Study group | Role | What they receive |
|---|---|---|
| AI+Chemo | Experimental | aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC*4-T*4) in patients with postmenopausal hormone receptor-positive breast cancer Receives: Drug: Letrozole (Aromatase Inhibitors); Drug: AC*4-T*4 |
| Chemo | Active comparator | chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer Receives: Drug: AC*4-T*4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective rate
CR+PR
Measured: half year after randomized
Secondary outcomes (3)
pCR
pathological CR
Measured: half year after randomized
disease-free survival (DFS)
disease-free survival
Measured: 2 years after randomized
side effect rate
Measured: 2 years after randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong-Jian Yang, MD., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769104
- Sponsor's protocol ID
- ZJCH-ACCN
- Acronym
- ACCN
- Status last verified
- Jan 2018
- First submitted
- 8 May 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The investigators have not decided if the data can be available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02769104
- Acronym / sponsor ID
- ACCN / ZJCH-ACCN
- Conditions
- Neoadjuvant Therapy
- Keywords
- aromatase inhibitors, chemotherapy, neoadjuvant, postmenopausal, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.
Detailed description
The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI+Chemo | Experimental | Drug: Letrozole (Aromatase Inhibitors), Drug: AC*4-T*4aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC*4-T*4) in patients with postmenopausal hormone receptor-positive breast cancer |
| Chemo | Active comparator | Drug: AC*4-T*4chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- provision of informed consent
- clinical stage IIA~IIIC
- histologically proven HR+ invasive breast cancer
- women defined as postmenopausal according to NCCN guideline
- plan to accept the neoadjuvant (pre operational) chemotherapy treatment
Key exclusion criteria (14 listed)
- clinical evidence of metastatic disease
- bilateral oophorectomy;
- radiation of the ovaries
- patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- patients who accepted anti-cancer treatment before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole (Aromatase Inhibitors)Also: LetrozoleLetrozole (Aromatase Inhibitors) for 5 years | Drug | AI+Chemo |
| AC*4-T*4Also: CTX+Anthracyclines, DocetaxelCTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles | Drug | AI+Chemo, Chemo |
Primary outcome
effective rate
Time frame: half year after randomized
CR+PR
3 secondary outcomes
pCR
Time frame: half year after randomized
disease-free survival (DFS)
Time frame: 2 years after randomized
side effect rate
Time frame: 2 years after randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided. The investigators have not decided if the data can be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong-Jian Yang, MD. contact
Hong-Jian Yang, MD. principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole (Aromatase Inhibitors) and AC*4-T*4 in people with Neoadjuvant Therapy, run by Zhejiang Cancer Hospital 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 5 inclusion and 14 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 9 Jan 2018. 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 Hong-Jian Yang, MD. (yhjzlyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective rate (time frame: half year after randomized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.