Breast NeoplasmPhase 2NCT00001250
Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
A Phase 2 study testing preoperative dose intense chemotherapy (FLAC/G-CSF) in people with Breast Neoplasm and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm, Neoplasm Metastasis
- What is being tested?
- preoperative dose intense chemotherapy (FLAC/G-CSF)
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1989to Oct 2002
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women of any age with clinical stage II breast cancer who met the following criteria:
- Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]).
- Patients will be staged according to the 1986 AJCC TMM classification.
- Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III.
- Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin.
- Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
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- Patients must be mentally competent to understand and give informed consent for the protocol.
- Estrogen receptor (ER) status can include ER positive, negative, or unknown.
- Patients with prior cancers may be eligible as long as they have received curative therapy and have had no evidence of recurrence for greater than or equal to 10 years.
Who cannot join
- Patients will be excluded from this protocol for the following reasons:
- Advanced local disease or distant metastases (stage III or IV).
- Previous therapy to the breast other than excisional biopsy.
- Pregnancy.
- Unwillingness to use birth control during chemotherapy.
- Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly.
Read the detailed description
A prospective randomized trial evaluating the effect of preoperative dose intense chemotherapy (FLAC/G-CSF) on axillary lymph node metastases in women with clinical stage II (T1N1, T2N0, T2N1) breast cancer. Patients will be randomized to receive 5 cycles of combination chemotherapy (5-FU, adriamycin, leucovorin, cytoxan, G-CSF) either as initial therapy (preoperative) or postoperatively after local therapy (modified radical mastectomy or lumpectomy/axillary lymph node dissection/whole breast radiotherapy). Each chemotherapy cycle will be 21 days. At the time of local therapy the incidence of axillary metastases in the axillary dissection specimen will be determined and compared in the preoperative chemotherapy vs. postoperative chemotherapy treatment groups.
- Conditions
- Breast Neoplasm, Neoplasm Metastasis
- Being tested
- preoperative dose intense chemotherapy (FLAC/G-CSF)
- Keywords
- Neoadjuvant Chemotherapy, Dose Intense Chemotherapy, Stage II Breast Cancer, Early Stage Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative dose intense chemotherapy (FLAC/G-CSF)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startDec 1989
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001250
- Sponsor's protocol ID
- 900044
- Other IDs
- 90-C-0044
- Status last verified
- Oct 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. doi: 10.1200/JCO.1986.4.6.929.
PubMed 3519883Bonadonna G, Valagussa P, Rossi A, Tancini G, Brambilla C, Zambetti M, Veronesi U. Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat. 1985;5(2):95-115. doi: 10.1007/BF01805984.
PubMed 3839424Early Breast Cancer Trialists' Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer. An overview of 61 randomized trials among 28,896 women. N Engl J Med. 1988 Dec 29;319(26):1681-92. doi: 10.1056/NEJM198812293192601.
PubMed 3205265
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00001250
- Acronym / sponsor ID
- 900044
- Conditions
- Breast Neoplasm, Neoplasm Metastasis
- Keywords
- Neoadjuvant Chemotherapy, Dose Intense Chemotherapy, Stage II Breast Cancer, Early Stage Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 1989
- Study completion
- Oct 2002
- First posted
- 4 Nov 1999 (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.
Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly.
Detailed description
A prospective randomized trial evaluating the effect of preoperative dose intense chemotherapy (FLAC/G-CSF) on axillary lymph node metastases in women with clinical stage II (T1N1, T2N0, T2N1) breast cancer. Patients will be randomized to receive 5 cycles of combination chemotherapy (5-FU, adriamycin, leucovorin, cytoxan, G-CSF) either as initial therapy (preoperative) or postoperatively after local therapy (modified radical mastectomy or lumpectomy/axillary lymph node dissection/whole breast radiotherapy). Each chemotherapy cycle will be 21 days. At the time of local therapy the incidence of axillary metastases in the axillary dissection specimen will be determined and compared in the preoperative chemotherapy vs. postoperative chemotherapy treatment groups.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically ([N0 or N1] [T1N1, T2N0, T2N1]).
- Patients will be staged according to the 1986 AJCC TMM classification.
- Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III.
- Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin.
- Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
Key exclusion criteria (6 listed)
- Advanced local disease or distant metastases (stage III or IV).
- Previous therapy to the breast other than excisional biopsy.
- Pregnancy.
- Unwillingness to use birth control during chemotherapy.
- Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina.
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 |
|---|---|---|
| preoperative dose intense chemotherapy (FLAC/G-CSF) | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3519883Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. doi: 10.1200/JCO.1986.4.6.929.
- Background: PubMed 3839424Bonadonna G, Valagussa P, Rossi A, Tancini G, Brambilla C, Zambetti M, Veronesi U. Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat. 1985;5(2):95-115. doi: 10.1007/BF01805984.
- Background: PubMed 3205265Early Breast Cancer Trialists' Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer. An overview of 61 randomized trials among 28,896 women. N Engl J Med. 1988 Dec 29;319(26):1681-92. doi: 10.1056/NEJM198812293192601.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing preoperative dose intense chemotherapy (FLAC/G-CSF) in people with Breast Neoplasm and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.
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 9 inclusion and 6 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 4 Mar 2008. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001250, which also lists 3 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 4 Mar 2008.