Breast CancerPhase 2NCT00603408
Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer
A Phase 2 study testing Cisplatin, Radiation Therapy and Mastectomy in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cisplatin, Radiation Therapy and Mastectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be >= 18 years of age
- Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
- Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
- Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
- Adequate organ function defined as:
- Serum Creatinine <= 1.5 x upper limit of institutional normal.
Show all 9Show fewer
- ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
- Bilirubin <= 1.5 x upper limit of institutional normal.
- Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.
Who cannot join
- No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.
- No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
- Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
- Karnofsky Performance Status of <= 70.
- Patients with known history neural deficiencies (e.g. peripheral neuropathy).
- Patients with a known hearing impairment (hearing loss or severe tinnitus).
- Male patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.
Read the detailed description
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative
Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative
Week 1: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy
Week 2: Radiation Day 1-5: Radiation Therapy
Week 3: Radiation Days 1-5: Radiation Therapy
Week 4: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 2) Days 2-5: Radiation Therapy
Week 5: Radiation Days 1-5: Radiation Therapy
Week 6: Radiation Days 1-5: Radiation Therapy
Week 7: Chemo Day 1: Cisplatin 75mg/m^2 (cycle 3)
Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (cycle 4)
Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration
Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m^2 \& Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles
Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 every 2 weeks for 4 cycles
Week 52 IVAD Removal, Bone marrow aspiration
Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5
- Conditions
- Breast Cancer
- Being tested
- Cisplatin, Radiation Therapy, Mastectomy
- Keywords
- Breast Cancer, Locally Advanced, Neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called cisplatinum
Radiation TherapyRadiation
MastectomyProcedure or surgery
(RECOMMENDED BUT NOT REQUIRED)
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin + Radiation + Recommended Surgery | Experimental | Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10
Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.
Surgery (recommended) mastectomy with/without axillary lymph node dissection Receives: Drug: Cisplatin; Radiation: Radiation Therapy; Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
- Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level
- Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
- Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,
- Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.
Measured: At the time of surgery (week 13)
Secondary outcomes (7)
Time to Disease Progression
Time to disease progression: time from registration until objective tumor progression; does not include deaths
Measured: Until study was terminated (23.5 months)
Overall Survival Rate (OS)
OS = Time from registration until death from any cause
Measured: Until study was terminated (23.5 months)
Number of Participants With Surgical Complications
Measured: 30 days post surgery (week 17-18)
Number of Participants With Medical Toxicities
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.
Measured: 30 days post surgery (week 17-18)
Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response
Measured: 5 years
Develop Animal Models of Triple Negative Breast Cancers
Measured: 5 years
Provide Samples for the Development of the FNA Assay
Measured: At time of IVAD placement and at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Study was discontinued due to lack of accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Aft, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603408
- Sponsor's protocol ID
- 07-0913
- Status last verified
- Jul 2016
- First submitted
- 28 Dec 2007
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.
PubMed 17329194Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
PubMed 11553815Carey LA, Perou CM, Livasy CA, Dressler LG, Cowan D, Conway K, Karaca G, Troester MA, Tse CK, Edmiston S, Deming SL, Geradts J, Cheang MC, Nielsen TO, Moorman PG, Earp HS, Millikan RC. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA. 2006 Jun 7;295(21):2492-502. doi: 10.1001/jama.295.21.2492.
PubMed 16757721Turner NC, Reis-Filho JS. Basal-like breast cancer and the BRCA1 phenotype. Oncogene. 2006 Sep 25;25(43):5846-53. doi: 10.1038/sj.onc.1209876.
PubMed 16998499Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
PubMed 17016441Garber, J., Richardson, A., Harris, L., Miron, A., Silver, D., Golshan, M., Ryan, P., Ganesan, S., Wang, Z., Clarke, K., Inglehart, J., and Winer, E. Neoadjuvant cisplatin in triple negative breast cancer. SABCS, 2006.
Bollet MA, Sigal-Zafrani B, Gambotti L, Extra JM, Meunier M, Nos C, Dendale R, Campana F, Kirova YM, Dieras V, Fourquet A; Institut Curie Breast Cancer Study Group. Pathological response to preoperative concurrent chemo-radiotherapy for breast cancer: results of a phase II study. Eur J Cancer. 2006 Sep;42(14):2286-95. doi: 10.1016/j.ejca.2006.03.026. Epub 2006 Aug 8.
PubMed 16893641Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.
PubMed 12610186Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. doi: 10.1200/JCO.1999.17.5.1339.
PubMed 10334517Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
PubMed 10202164Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. doi: 10.1056/NEJM199904153401503.
PubMed 10202166Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995 Apr 13;332(15):1004-14. doi: 10.1056/NEJM199504133321507. No abstract available.
PubMed 7885406Rowinsky EK, Chaudhry V, Forastiere AA, Sartorius SE, Ettinger DS, Grochow LB, Lubejko BG, Cornblath DR, Donehower RC. Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J Clin Oncol. 1993 Oct;11(10):2010-20. doi: 10.1200/JCO.1993.11.10.2010.
PubMed 7692001Diel IJ, Cote RJ. Bone marrow and lymph node assessment for minimal residual disease in patients with breast cancer. Cancer Treat Rev. 2000 Feb;26(1):53-65. doi: 10.1053/ctrv.1999.0150.
PubMed 10660491Braun S, Pantel K, Muller P, Janni W, Hepp F, Kentenich CR, Gastroph S, Wischnik A, Dimpfl T, Kindermann G, Riethmuller G, Schlimok G. Cytokeratin-positive cells in the bone marrow and survival of patients with stage I, II, or III breast cancer. N Engl J Med. 2000 Feb 24;342(8):525-33. doi: 10.1056/NEJM200002243420801.
PubMed 10684910
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
- ClinicalTrials.gov ID
- NCT00603408
- Acronym / sponsor ID
- 07-0913
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Locally Advanced, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was discontinued due to lack of accrual.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.
Detailed description
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative
Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative
Week 1: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy
Week 2: Radiation Day 1-5: Radiation Therapy
Week 3: Radiation Days 1-5: Radiation Therapy
Week 4: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 2) Days 2-5: Radiation Therapy
Week 5: Radiation Days 1-5: Radiation Therapy
Week 6: Radiation Days 1-5: Radiation Therapy
Week 7: Chemo Day 1: Cisplatin 75mg/m^2 (cycle 3)
Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (cycle 4)
Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration
Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m^2 \& Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles
Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 every 2 weeks for 4 cycles
Week 52 IVAD Removal, Bone marrow aspiration
Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin + Radiation + Recommended Surgery | Experimental | Drug: Cisplatin, Radiation: Radiation Therapy, Procedure: MastectomyCisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10 Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks. Surgery (recommended) mastectomy with/without axillary lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be >= 18 years of age
- Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
- Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
- Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
- Adequate organ function defined as:
Key exclusion criteria (7 listed)
- No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.
- No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
- Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
- Karnofsky Performance Status of <= 70.
- Patients with known history neural deficiencies (e.g. peripheral neuropathy).
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 |
|---|---|---|
| CisplatinAlso: cisplatinum | Drug | Cisplatin + Radiation + Recommended Surgery |
| Radiation Therapy | Radiation | Cisplatin + Radiation + Recommended Surgery |
| Mastectomy(RECOMMENDED BUT NOT REQUIRED) | Procedure or surgery | Cisplatin + Radiation + Recommended Surgery |
Primary outcome
Overall Response
Time frame: At the time of surgery (week 13)
* Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level * Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD * Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, * Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.
7 secondary outcomes
Time to Disease Progression
Time frame: Until study was terminated (23.5 months)
Overall Survival Rate (OS)
Time frame: Until study was terminated (23.5 months)
Number of Participants With Surgical Complications
Time frame: 30 days post surgery (week 17-18)
Number of Participants With Medical Toxicities
Time frame: 30 days post surgery (week 17-18)
Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response
Time frame: 5 years
Develop Animal Models of Triple Negative Breast Cancers
Time frame: 5 years
Provide Samples for the Development of the FNA Assay
Time frame: At time of IVAD placement and at time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17329194Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.
- Background: PubMed 11553815Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
- Background: PubMed 16757721Carey LA, Perou CM, Livasy CA, Dressler LG, Cowan D, Conway K, Karaca G, Troester MA, Tse CK, Edmiston S, Deming SL, Geradts J, Cheang MC, Nielsen TO, Moorman PG, Earp HS, Millikan RC. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA. 2006 Jun 7;295(21):2492-502. doi: 10.1001/jama.295.21.2492.
- Background: PubMed 16998499Turner NC, Reis-Filho JS. Basal-like breast cancer and the BRCA1 phenotype. Oncogene. 2006 Sep 25;25(43):5846-53. doi: 10.1038/sj.onc.1209876.
- Background: PubMed 17016441Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
- BackgroundGarber, J., Richardson, A., Harris, L., Miron, A., Silver, D., Golshan, M., Ryan, P., Ganesan, S., Wang, Z., Clarke, K., Inglehart, J., and Winer, E. Neoadjuvant cisplatin in triple negative breast cancer. SABCS, 2006.
- Background: PubMed 16893641Bollet MA, Sigal-Zafrani B, Gambotti L, Extra JM, Meunier M, Nos C, Dendale R, Campana F, Kirova YM, Dieras V, Fourquet A; Institut Curie Breast Cancer Study Group. Pathological response to preoperative concurrent chemo-radiotherapy for breast cancer: results of a phase II study. Eur J Cancer. 2006 Sep;42(14):2286-95. doi: 10.1016/j.ejca.2006.03.026. Epub 2006 Aug 8.
- Background: PubMed 12610186Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.
- Background: PubMed 10334517Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. doi: 10.1200/JCO.1999.17.5.1339.
- Background: PubMed 10202164Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
- Background: PubMed 10202166Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. doi: 10.1056/NEJM199904153401503.
- Background: PubMed 7885406Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995 Apr 13;332(15):1004-14. doi: 10.1056/NEJM199504133321507. No abstract available.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Rebecca Aft, MD, PhD principal investigator
Washington University School of Medicine
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 Cisplatin, Radiation Therapy and Mastectomy in people with Breast Cancer, run by Washington University School of Medicine 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 7 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: stopped early, as of the sponsor's last update on 19 Aug 2016. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Response (time frame: At the time of surgery (week 13)). 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 NCT00603408, which also lists 17 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 19 Aug 2016.