Breast CancerPhase 3NCT00516425
Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer
A Phase 3 study testing pegfilgrastim, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer, run by Charing Cross Hospital at 2 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pegfilgrastim, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2007to not given
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast carcinoma
- Primary operable breast cancer that was surgically treated by wide local excision or mastectomy with clear margins (> 1 mm apart from deep margin if full thickness resection)
- No more than 8 weeks since prior definitive surgery
- Early-stage disease with no evidence of metastases clinically or on routine staging investigations
- No T4 and/or N3 disease
- Prior axillary staging required, including 1 of the following:
- Sentinel node biopsy
- Axillary sampling or clearance
- All node-positive patients must have had axillary clearance or radiotherapy to the axilla
- Must be at high risk of relapse within 5 years (risk factors evaluated at clinician's discretion)
- No other invasive breast cancer, systemically treated ductal carcinoma in situ (DCIS), or solid tumor within the past 5 years
- No prior hematologic malignancy or melanoma
- Hormone receptor status:
- Estrogen receptor (ER)- or progesterone receptor (PR)-negative OR ER/PR-weakly positive (e.g., Allred/Quick score ≤ 5 OR H score ≤ 100)
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- Performance status 0-1
- Hemoglobin > 9 g/dL
- WBC > 3,000/mm³
- Platelet count > 100,000/mm³
- Bilirubin normal (unless known Gilbert's disease is present)
- Albumin normal
- AST and ALT ≤ 1.5 x upper limit of normal (ULN)
- Creatinine ≤ 1.5 x ULN
- Creatinine clearance > 50 mL/min
- No active or uncontrolled infection
- Must be available for routine long-term hospital follow-up
- Must have normal cardiac function and no significant cardiac disease by ECHO or MUGA
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior preoperative endocrine therapy
- No prior systemic therapy for this breast cancer or mantle radiotherapy
- No prior breast-conserving surgery in which there is a contraindication for, or decline of postoperative radiotherapy
- No concurrent hormone replacement therapy (HRT)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
Robert C.F. Leonard, MD, BS, MB, 44-208-846-7237
- Recruiting
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Anne Robinson, MD, 44-1702-221-226
About this study
Official title: Adjuvant Cytotoxic Chemotherapy In Older Women
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving doxorubicin or epirubicin together with cyclophosphamide is more effective than observation in treating older women with invasive breast cancer.
PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and cyclophosphamide to see how well they work compared with observation in treating older women with invasive breast cancer.
Read the detailed description
OBJECTIVES:
- To provide evidence for extending the current standard care in older women with invasive breast carcinoma treated with adjuvant chemotherapy comprising doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide.
- Compare the relapse-free survival interval of these patients treated with adjuvant chemotherapy vs no adjuvant chemotherapy.
- Compare the toxicity of accelerated adjuvant chemotherapy with pegfilgrastim support vs non-accelerated adjuvant chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and indication for endocrine therapy (yes vs no). Patients are randomized to 1 of 2 arms.
- Arm I (observation): Patients do not receive adjuvant chemotherapy.
- Arm II (adjuvant chemotherapy): Patients are randomized to 1 of 2 chemotherapy regimens.
- Accelerated adjuvant chemotherapy: Patients receive doxorubicin hydrochloride and cyclophosphamide (AC) OR epirubicin hydrochloride and cyclophosphamide (EC) on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Non-accelerated adjuvant chemotherapy: Patients receive AC or EC on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection for biological, pharmacological, and proteomic studies. Samples are initially used to establish a resource of materials available for different research groups. Samples are also analyzed using SELDI or MALDI-ToF technology to identify biological profiles that correlate with prognosis or predict response to treatment.
Quality of life is assessed at baseline, 6 weeks, 1 month, 6 months, 9 months, 12 months, 18 months, and 24 months.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
- Conditions
- Breast Cancer
- Being tested
- pegfilgrastim, cyclophosphamide, doxorubicin hydrochloride, epirubicin hydrochloride, proteomic profiling
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA 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.
pegfilgrastimBiological
cyclophosphamideDrug
epirubicin hydrochlorideDrug
proteomic profilingGenetic
diagnostic laboratory biomarker analysisOther
matrix-assisted laser desorption/ionization time of flight mass spectrometryOther
surface-enhanced laser desorption/ionization-time of flight mass spectrometryOther
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free interval
Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI)
Total FACT-AN score
Total FACT-F score
Secondary outcomes (9)
Disease-free survival
Overall survival
Cause-specific survival
Distant disease-free survival
Safety and tolerability (overall and for each treatment schedule)
Treatment compliance (overall and for each treatment schedule)
Quality of life
Total FACT-B score
Individual subscales on activities of daily living
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charing Cross Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Robert C.F. Leonard, MD, BS, MB, Principal investigator, Charing Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516425
- Sponsor's protocol ID
- UKM-CCH-ACTION
- Other IDs
- CDR0000561076, ICR-CTSU/2006/10004-ACTION, EU-20751, EUDRACT-2005-005721, ISRCTN41708421, BIG-205
- Status last verified
- Sep 2007
- First submitted
- 14 Aug 2007
- Last updated
- 7 Aug 2013
- Results posted
- No
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
- Adjuvant Cytotoxic Chemotherapy In Older Women
- ClinicalTrials.gov ID
- NCT00516425
- Acronym / sponsor ID
- UKM-CCH-ACTION
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charing Cross HospitalUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 15 Aug 2007 (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, such as doxorubicin, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving doxorubicin or epirubicin together with cyclophosphamide is more effective than observation in treating older women with invasive breast cancer.
PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and cyclophosphamide to see how well they work compared with observation in treating older women with invasive breast cancer.
Detailed description
OBJECTIVES:
- To provide evidence for extending the current standard care in older women with invasive breast carcinoma treated with adjuvant chemotherapy comprising doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide.
- Compare the relapse-free survival interval of these patients treated with adjuvant chemotherapy vs no adjuvant chemotherapy.
- Compare the toxicity of accelerated adjuvant chemotherapy with pegfilgrastim support vs non-accelerated adjuvant chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and indication for endocrine therapy (yes vs no). Patients are randomized to 1 of 2 arms.
- Arm I (observation): Patients do not receive adjuvant chemotherapy.
- Arm II (adjuvant chemotherapy): Patients are randomized to 1 of 2 chemotherapy regimens.
- Accelerated adjuvant chemotherapy: Patients receive doxorubicin hydrochloride and cyclophosphamide (AC) OR epirubicin hydrochloride and cyclophosphamide (EC) on day 1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Non-accelerated adjuvant chemotherapy: Patients receive AC or EC on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection for biological, pharmacological, and proteomic studies. Samples are initially used to establish a resource of materials available for different research groups. Samples are also analyzed using SELDI or MALDI-ToF technology to identify biological profiles that correlate with prognosis or predict response to treatment.
Quality of life is assessed at baseline, 6 weeks, 1 month, 6 months, 9 months, 12 months, 18 months, and 24 months.
After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| pegfilgrastim | Biological | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| proteomic profiling | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | – |
| pharmacological study | Other | – |
| surface-enhanced laser desorption/ionization-time of flight mass spectrometry | Other | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Relapse-free interval
Physical, functional, and breast cancer concerns as measured by the Trial Outcome Index (TOI)
Total FACT-AN score
Total FACT-F score
9 secondary outcomes
Disease-free survival
Overall survival
Cause-specific survival
Distant disease-free survival
Safety and tolerability (overall and for each treatment schedule)
Treatment compliance (overall and for each treatment schedule)
Quality of life
Total FACT-B score
Individual subscales on activities of daily living
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.
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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.
Robert C.F. Leonard, MD, BS, MB principal investigator
Charing Cross Hospital
2 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 pegfilgrastim, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer, run by Charing Cross Hospital at 2 sites in United Kingdom.
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 2 sites in United Kingdom. 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?
Relapse-free interval. The study lists 4 primary outcomes in all. 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 7 Aug 2013.