Breast CancerPhase 3NCT00629278
Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer
A Phase 3 study testing trastuzumab, aromatase inhibition therapy and cyclophosphamide in people with Breast Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 6 sites in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab, aromatase inhibition therapy and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 6 sitesItaly
- Study dates
- Dec 2007to Dec 2010
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of infiltrating primary breast cancer
- Stage I-IIIA disease
- Resected tumor with free margins (i.e., no neoplastic cells on the resected margin)
- Must have node-negative sentinel node or complete axillary clearance
- Axillary clearance required for micrometastasis (between 0.2 and 2 mm) in the sentinel node but not for isolated tumor cells
- Treatment is scheduled to begin within 10 weeks from the date of surgery
- Date of the last surgery will be taken into account for patients undergoing re-excision of positive margins or axillary lymph node dissection after positive sentinel node biopsy
- Node positivity or node negativity AND ≥ 1 of the following:
- T > 2 cm
- Grade 3
- Presence of lymphovascular invasion
- Ki 67 > 20%
- Age 35 years
- Hormone receptor negativity (<10%)
- HER2-positive tumor (3+ by IHC or FISH+ according to the American Society of Clinical Oncology guidelines [i.e., > 2.2; in case of polysomy, with ≥ 6 gene copies])
- Estrogen receptor-positive and/or progesterone receptor-positive disease
PATIENT CHARACTERISTICS:
- Female
- Pre- or postmenopausal status
- Postmenopausal status defined by ≥ 1 of the following:
- At least 60 years of age
- Less than 60 years of age and amenorrheic for ≥ 12 months prior to day 1
- Less than 60 years of age and amenorrheic for < 12 months prior to day 1 with luteinizing hormone and follicle-stimulating hormone values within postmenopausal range OR without a uterus
- Prior bilateral oophorectomy
- Prior radiation castration with amenorrhea for ≥ 6 months
- ECOG performance status 0-1
- Suitable for adjuvant chemotherapy
- WBC > 3,000/mcL
- ANC > 1,500/mcL
- Platelet count >100,000/mcL
- Total bilirubin normal
- AST and ALT 2.5 times upper limit of normal
- Creatinine normal
- Cardiac ejection fraction normal as measured by ECHO or MUGA scan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
- No contraindication to anthracycline, cyclophosphamide, fluorouracil, paclitaxel, or trastuzumab (Herceptin®) treatment
- No uncontrolled intercurrent illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- See Patient Characteristics
- No prior chemotherapy, endocrine therapy, or radiotherapy
- No other concurrent investigational agents
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Ospedale Santa Croce
Cuneo, 12100
Contact Person, 39-0171-441-309
- Recruiting
Ospedale Civile di Ivrea
Ivrea, 10015
Contact Person, 39-0125-4141
- Recruiting
Azienda Ospedaliera - Universitaria di Modena
Modena, 41100
Pier Franco Conte, MD, 39-059-422-4538, conte.pierfranco@unimo.it
- Recruiting
Piacenza Hospital
Piacenza, 29100
Contact Person, 39-052-330-3123
- Recruiting
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, 10126
Contact Person, 39-011-633-1633
- Recruiting
Ospedal San Andrea
Vercelli, 13100
Contact Person, 39-161-593-418
About this study
Official title: SHORT-HER: MULTICENTRIC RANDOMISED PHASE III TRIAL OF 2 DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENS PLUS 3 VS 12 MONTHS OF TRASTUZUMAB IN HER2 POSITIVE BREAST CANCER PATIENTS
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with trastuzumab is most effective in treating breast cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of combination chemotherapy given together with trastuzumab to see how well they work in treating women with HER2-positive stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate if 3 months of trastuzumab (Herceptin®) administered according to the Finnish protocol (9-weekly administrations) is not inferior to 12 months (18 three-weekly administrations) in a standard chemotherapy protocol, in terms of disease-free survival, in patients with HER2-positive early breast cancer.
- To determine overall survival of patients treated with these regimens.
Secondary
- To determine the failure rate at 2 years, calculated as cumulative incidence of relapse, contralateral breast cancer (excluding in situ carcinoma), death for all causes, and treatment withdrawal due to toxicity of therapy.
- To determine the incidence of cardiac events (defined as decrease of ejection fraction (EF) over 15% from basal values, or decrease over 10% with EF absolute value below 50%, or symptomatic cardiac failure, or other cardiac side effects grade 2 or more according to NCI CTCAE v.3.
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status (positive vs negative), hormone-receptor status (estrogen receptor-positive vs progesterone receptor-positive disease), and Regional Coordinating Center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard long-term adjuvant treatment-12 months): Patients receive chemotherapy comprising either doxorubicin hydrochloride IV and cyclophosphamide IV or epirubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive paclitaxel IV over 3 hours or docetaxel* IV over 1 hour and concurrent trastuzumab (Herceptin®) IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses.
NOTE: *Patients < 65 years old receive a higher dose of docetaxel and patients ≥ 65 years old receive a lower dose of docetaxel.
After completion of chemotherapy and concurrent trastuzumab, patients receive trastuzumab IV over 30-60 minutes as monotherapy every 21 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (experimental short-term adjuvant treatment-3 months): Patients receive docetaxel** IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats weekly for up to 9 weeks (9 doses).
Within 21 days after completion of docetaxel therapy, patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for up to 3 courses.
NOTE: **Patients < 65 years old receive a higher dose of docetaxel and patients ≥ 65 years old receive a lower dose of docetaxel.
In both arms, patients treated with conservative surgery or those with more than 4 positive axillary nodes undergo radiotherapy within 8 weeks after completion of chemotherapy. Patients enrolled in arm I undergo radiotherapy concurrently with trastuzumab.
Patients with hormone receptor-positive tumor (i.e., estrogen receptor and/or progesterone receptor-positive tumor) also receive hormonal treatment after completion of chemotherapy. Patients enrolled in arm I receive hormonal therapy concurrently with trastuzumab.
Premenopausal patients receive monthly luteinizing-hormone releasing-hormone agonist for 2 years plus daily tamoxifen citrate for 5 years. Post-menopausal patients receive an aromatase inhibitor daily for 5 years.
After completion of study therapy, patients are followed for up to 3 years.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, aromatase inhibition therapy, cyclophosphamide, docetaxel, doxorubicin hydrochloride
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, HER2-positive 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.
trastuzumabBiological
aromatase inhibition therapyDrug
cyclophosphamideDrug
docetaxelDrug
epirubicin hydrochlorideDrug
fluorouracilDrug
paclitaxelDrug
releasing hormone agonist therapyDrug
tamoxifen citrateDrug
adjuvant therapyProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Overall survival
Secondary outcomes (2)
Failure rate at 2 years due to relapse, death, or toxicity
Incidence of cardiac events as assessed by NCI CTCAE V3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Investigators
- Pier Franco Conte, MD, Principal investigator, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629278
- Sponsor's protocol ID
- AOUMODENA-SHORT-HER
- Other IDs
- CDR0000584446, EUDRACT-2007-004326-25, EU-20825
- Status last verified
- Jul 2009
- First submitted
- 4 Mar 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Guarneri V, Frassoldati A, Bruzzi P, D'Amico R, Belfiglio M, Molino A, Bertetto O, Cascinu S, Cognetti F, Di Leo A, Pronzato P, Crino L, Agostara B, Conte P. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278). Clin Breast Cancer. 2008 Oct;8(5):453-6. doi: 10.3816/CBC.2008.n.056.
PubMed 18952561Conte P, Bisagni G, Piacentini F, Sarti S, Minichillo S, Anselmi E, Aieta M, Gebbia V, Schirone A, Musolino A, Garrone O, Beano A, Rimanti A, Giotta F, Turletti A, Miglietta F, Dieci MV, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine-Week Versus One-Year Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 10-Year Update of the ShortHER Phase III Randomized Trial. J Clin Oncol. 2023 Nov 10;41(32):4976-4981. doi: 10.1200/JCO.23.00790. Epub 2023 Sep 25.
PubMed 37748109Dieci MV, Bisagni G, Bartolini S, Frassoldati A, Vicini R, Balduzzi S, D'amico R, Conte P, Guarneri V. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023 Feb 4;9(1):6. doi: 10.1038/s41523-023-00509-2.
PubMed 36739285Dieci MV, Bisagni G, Brandes AA, Frassoldati A, Cavanna L, Giotta F, Aieta M, Gebbia V, Musolino A, Garrone O, Donadio M, Rimanti A, Beano A, Zamagni C, Soto Parra H, Piacentini F, Danese S, Ferro A, Cagossi K, Sarti S, Gambaro AR, Romito S, Bazan V, Amaducci L, Moretti G, Foschini MP, Balduzzi S, Vicini R, D'Amico R, Griguolo G, Guarneri V, Conte PF. Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial. BMC Med. 2019 Nov 21;17(1):207. doi: 10.1186/s12916-019-1445-z.
PubMed 31747948Conte P, Frassoldati A, Bisagni G, Brandes AA, Donadio M, Garrone O, Piacentini F, Cavanna L, Giotta F, Aieta M, Gebbia V, Molino A, Musolino A, Ferro A, Maltoni R, Danese S, Zamagni C, Rimanti A, Cagossi K, Russo A, Pronzato P, Giovanardi F, Moretti G, Lombardo L, Schirone A, Beano A, Amaducci L, Bajardi EA, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER studydouble dagger. Ann Oncol. 2018 Dec 1;29(12):2328-2333. doi: 10.1093/annonc/mdy414.
PubMed 30219886
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHORT-HER: MULTICENTRIC RANDOMISED PHASE III TRIAL OF 2 DIFFERENT ADJUVANT CHEMOTHERAPY REGIMENS PLUS 3 VS 12 MONTHS OF TRASTUZUMAB IN HER2 POSITIVE BREAST CANCER PATIENTS
- ClinicalTrials.gov ID
- NCT00629278
- Acronym / sponsor ID
- AOUMODENA-SHORT-HER
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, HER2-positive breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (estimated)
- First posted
- 5 Mar 2008 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with trastuzumab is most effective in treating breast cancer.
PURPOSE: This randomized phase III trial is comparing two different regimens of combination chemotherapy given together with trastuzumab to see how well they work in treating women with HER2-positive stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate if 3 months of trastuzumab (Herceptin®) administered according to the Finnish protocol (9-weekly administrations) is not inferior to 12 months (18 three-weekly administrations) in a standard chemotherapy protocol, in terms of disease-free survival, in patients with HER2-positive early breast cancer.
- To determine overall survival of patients treated with these regimens.
Secondary
- To determine the failure rate at 2 years, calculated as cumulative incidence of relapse, contralateral breast cancer (excluding in situ carcinoma), death for all causes, and treatment withdrawal due to toxicity of therapy.
- To determine the incidence of cardiac events (defined as decrease of ejection fraction (EF) over 15% from basal values, or decrease over 10% with EF absolute value below 50%, or symptomatic cardiac failure, or other cardiac side effects grade 2 or more according to NCI CTCAE v.3.
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status (positive vs negative), hormone-receptor status (estrogen receptor-positive vs progesterone receptor-positive disease), and Regional Coordinating Center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (standard long-term adjuvant treatment-12 months): Patients receive chemotherapy comprising either doxorubicin hydrochloride IV and cyclophosphamide IV or epirubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive paclitaxel IV over 3 hours or docetaxel* IV over 1 hour and concurrent trastuzumab (Herceptin®) IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses.
NOTE: *Patients < 65 years old receive a higher dose of docetaxel and patients ≥ 65 years old receive a lower dose of docetaxel.
After completion of chemotherapy and concurrent trastuzumab, patients receive trastuzumab IV over 30-60 minutes as monotherapy every 21 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (experimental short-term adjuvant treatment-3 months): Patients receive docetaxel** IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients also receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats weekly for up to 9 weeks (9 doses).
Within 21 days after completion of docetaxel therapy, patients receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for up to 3 courses.
NOTE: **Patients < 65 years old receive a higher dose of docetaxel and patients ≥ 65 years old receive a lower dose of docetaxel.
In both arms, patients treated with conservative surgery or those with more than 4 positive axillary nodes undergo radiotherapy within 8 weeks after completion of chemotherapy. Patients enrolled in arm I undergo radiotherapy concurrently with trastuzumab.
Patients with hormone receptor-positive tumor (i.e., estrogen receptor and/or progesterone receptor-positive tumor) also receive hormonal treatment after completion of chemotherapy. Patients enrolled in arm I receive hormonal therapy concurrently with trastuzumab.
Premenopausal patients receive monthly luteinizing-hormone releasing-hormone agonist for 2 years plus daily tamoxifen citrate for 5 years. Post-menopausal patients receive an aromatase inhibitor daily for 5 years.
After completion of study therapy, patients are followed for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| trastuzumab | Biological | – |
| aromatase inhibition therapy | Drug | – |
| cyclophosphamide | Drug | – |
| docetaxel | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| fluorouracil | Drug | – |
| paclitaxel | Drug | – |
| releasing hormone agonist therapy | Drug | – |
| tamoxifen citrate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Disease-free survival
Overall survival
2 secondary outcomes
Failure rate at 2 years due to relapse, death, or toxicity
Incidence of cardiac events as assessed by NCI CTCAE V3.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Results publication: PubMed 18952561Guarneri V, Frassoldati A, Bruzzi P, D'Amico R, Belfiglio M, Molino A, Bertetto O, Cascinu S, Cognetti F, Di Leo A, Pronzato P, Crino L, Agostara B, Conte P. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278). Clin Breast Cancer. 2008 Oct;8(5):453-6. doi: 10.3816/CBC.2008.n.056.
- Derived from this study: PubMed 37748109Conte P, Bisagni G, Piacentini F, Sarti S, Minichillo S, Anselmi E, Aieta M, Gebbia V, Schirone A, Musolino A, Garrone O, Beano A, Rimanti A, Giotta F, Turletti A, Miglietta F, Dieci MV, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine-Week Versus One-Year Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 10-Year Update of the ShortHER Phase III Randomized Trial. J Clin Oncol. 2023 Nov 10;41(32):4976-4981. doi: 10.1200/JCO.23.00790. Epub 2023 Sep 25.
- Derived from this study: PubMed 36739285Dieci MV, Bisagni G, Bartolini S, Frassoldati A, Vicini R, Balduzzi S, D'amico R, Conte P, Guarneri V. Type of adjuvant endocrine therapy and disease-free survival in patients with early HR-positive/HER2-positive BC: analysis from the phase III randomized ShortHER trial. NPJ Breast Cancer. 2023 Feb 4;9(1):6. doi: 10.1038/s41523-023-00509-2.
- Derived from this study: PubMed 31747948Dieci MV, Bisagni G, Brandes AA, Frassoldati A, Cavanna L, Giotta F, Aieta M, Gebbia V, Musolino A, Garrone O, Donadio M, Rimanti A, Beano A, Zamagni C, Soto Parra H, Piacentini F, Danese S, Ferro A, Cagossi K, Sarti S, Gambaro AR, Romito S, Bazan V, Amaducci L, Moretti G, Foschini MP, Balduzzi S, Vicini R, D'Amico R, Griguolo G, Guarneri V, Conte PF. Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial. BMC Med. 2019 Nov 21;17(1):207. doi: 10.1186/s12916-019-1445-z.
- Derived from this study: PubMed 30219886Conte P, Frassoldati A, Bisagni G, Brandes AA, Donadio M, Garrone O, Piacentini F, Cavanna L, Giotta F, Aieta M, Gebbia V, Molino A, Musolino A, Ferro A, Maltoni R, Danese S, Zamagni C, Rimanti A, Cagossi K, Russo A, Pronzato P, Giovanardi F, Moretti G, Lombardo L, Schirone A, Beano A, Amaducci L, Bajardi EA, Vicini R, Balduzzi S, D'Amico R, Guarneri V. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER studydouble dagger. Ann Oncol. 2018 Dec 1;29(12):2328-2333. doi: 10.1093/annonc/mdy414.
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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.
Pier Franco Conte, MD principal investigator
Azienda Ospedaliero-Universitaria di Modena
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trastuzumab, aromatase inhibition therapy and cyclophosphamide in people with Breast Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival. The study lists 2 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 NCT00629278, which also lists 5 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 7 Aug 2013.