Early Stage Breast CancerPhase 3NCT00309569
Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients
A Phase 3 study testing Cyclophosphamide, Methotrexate and Fluorouracil in people with Early Stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.
Trial summary
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Cyclophosphamide, Methotrexate and Fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- No sites listed yet
- Study dates
- Oct 1991to Sep 2000
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bioptically verified breast cancer
- Estrogen receptor-negative status
- Age: < 70 years
- WHO Performance Status < 2
- Laboratory parameters
- hematopoiesis: > 3500/mm3 leukocytes, > 100,000/mm3 thrombocytes
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- renal function: creatinin < 1.5mg%
- hepatic function: GOT max. 2.5 x UNL
- bilirubin: < 2.0 mg %
- metabolic parameters: Na, Ca, K in normal range
- </= 4 weeks interval since surgery
- Informed consent
Who cannot join
- Patients with locally inoperable cancer, M1
- Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
- Pregnancy or lactation
- General contraindication against cytostatic treatment
- T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
- Lacking compliance or understanding of disease
- Serious concomitant disease
- Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
About this study
Official title: A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Cyclophosphamide, Methotrexate, Fluorouracil, Epirubicin, Surgery
- Keywords
- Cyclophosphamide, Methotrexate, Fluorouracil, Epirubicine, 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.
CyclophosphamideDrug
Cyclophosphamide 600mg/m2
MethotrexateDrug
Methotrexate 40mg/m2
FluorouracilDrug
Fluorouracil 600mg/m2
EpirubicinDrug
Epirubucin 60mg/m2 (only node-positive patients)
SurgeryOther
Surgery
| Study group | Role | What they receive |
|---|---|---|
| A (pre- + postoperative chemotherapy) | Experimental | 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. Receives: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil; Drug: Epirubicin; Other: Surgery |
| B (conventional postoperative chemotherapy) | Experimental | Surgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. Receives: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Fluorouracil; Drug: Epirubicin; Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Recurrence-free survival
Secondary outcomes (1)
Rate of breast-conserving procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startOct 1991
- Primary completionSep 2000
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raimund Jakesz, MD, Principal investigator, Austrian Breast & Colorectal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309569
- Sponsor's protocol ID
- ABCSG-7
- Status last verified
- Oct 2020
- First submitted
- 31 Mar 2006
- Last updated
- 14 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00309569
- Acronym / sponsor ID
- ABCSG-7
- Conditions
- Early Stage Breast Cancer
- Keywords
- Cyclophosphamide, Methotrexate, Fluorouracil, Epirubicine, Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Austrian Breast & Colorectal Cancer Study GroupResearch network
- Study start
- Oct 1991 (actual)
- Primary completion
- Sep 2000 (actual)
- Study completion
- Sep 2000 (actual)
- First posted
- 3 Apr 2006 (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.
Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (pre- + postoperative chemotherapy) | Experimental | Drug: Cyclophosphamide, Drug: Methotrexate, Drug: Fluorouracil, Drug: Epirubicin, Other: Surgery3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil) followed by surgery. Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. |
| B (conventional postoperative chemotherapy) | Experimental | Drug: Cyclophosphamide, Drug: Methotrexate, Drug: Fluorouracil, Drug: Epirubicin, Other: SurgerySurgery followed by 3 cycles CMF (cyclophophamide + Methotrexat + 5-Fluorouracil). Subsequently node-positive patients received 3 cycles anthracycline-based chemotherapy regime EC (epirubicin + cyclophosphamide) and node-negative patients another 3 cycles CMF. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with bioptically verified breast cancer
- Estrogen receptor-negative status
- Age: < 70 years
- WHO Performance Status < 2
- Laboratory parameters
Key exclusion criteria (8 listed)
- Patients with locally inoperable cancer, M1
- Other preoperative tumor-specific radiotherapy, chemotherapy or endocrine treatment
- Pregnancy or lactation
- General contraindication against cytostatic treatment
- T4 cancer; inflammatory disease, simultaneous or sequential bilateral breast cancer
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 |
|---|---|---|
| CyclophosphamideCyclophosphamide 600mg/m2 | Drug | A (pre- + postoperative chemotherapy), B (conventional postoperative chemotherapy) |
| MethotrexateMethotrexate 40mg/m2 | Drug | A (pre- + postoperative chemotherapy), B (conventional postoperative chemotherapy) |
| FluorouracilFluorouracil 600mg/m2 | Drug | A (pre- + postoperative chemotherapy), B (conventional postoperative chemotherapy) |
| EpirubicinEpirubucin 60mg/m2 (only node-positive patients) | Drug | A (pre- + postoperative chemotherapy), B (conventional postoperative chemotherapy) |
| SurgerySurgery | Other | A (pre- + postoperative chemotherapy), B (conventional postoperative chemotherapy) |
Primary outcome
Overall survival
Recurrence-free survival
1 secondary outcome
Rate of breast-conserving procedures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Related InfoLink provided by the sponsor.
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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.
Raimund Jakesz, MD principal investigator
Austrian Breast & Colorectal Cancer Study Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Methotrexate and Fluorouracil in people with Early Stage Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group.
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 12 inclusion and 8 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall 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?
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 14 Oct 2020.