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Breast NeoplasmsPhase 2NCT00242203

Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

A Phase 2 study testing Zometa, Epirubicin and Docetaxel in people with Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Zometa, Epirubicin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Oct 2002to May 2011
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma
  • Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2
  • Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now > 5 years disease free
  • >= 18 years of age
  • Normal left ventricular function by echocardiogram or radioventriculogram
  • Karnofsky Performance >= 70

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 may be further clarified by additional testing such as PET or MRI
  • No current treatment with Zometa or other bisphosphonates
  • No serious functional disorders of the liver or kidneys:
  • Serum Creatinine <=2
  • ALT/AST/ALK Phos <= 1.5 x upper limit of institutional normal.
  • Bili <= 1.5 x upper limit of institutional normal.
  • Currently not pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.

Being tested
Zometa, Epirubicin, Docetaxel, Trastuzumab, External beam radiation
Keywords
Breast Cancer, Neoadjuvant, Micrometastasis
Medical subject headings
Breast Neoplasms, Neoplasm Micrometastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZometaDrug

    Also called Zoledronic acid

  • EpirubicinDrug

    Also called Ellence

  • DocetaxelDrug

    Also called Taxotere

  • TrastuzumabDrug

    Also called Herceptin

    ONLY for patients that are Her-2 overexpressing by 3+ by ICH for FSH

  • External beam radiationRadiation

  • Modified radical mastectomy or breast conserving surgery with axillary lymph node dissectionProcedure or surgery

Study groups in NCT00242203
Study groupRoleWhat they receive
ZometaExperimentalZometa 4 mg IV every 3 weeks for a total of 17 doses. The first treatment will be given at the time of the first chemotherapy treatment and will continue for approximately 1 year. Neoadjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery * Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 2 cycles * Docetaxel 75 mg/m2 IV every 21 days for 2 cycles * All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks
Receives: Drug: Zometa; Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab; Radiation: External beam radiation; Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
No ZometaActive comparatorNeoadjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery * Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 2 cycles * Docetaxel 75 mg/m2 IV every 21 days for 2 cycles * All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks
Receives: Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab; Radiation: External beam radiation; Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases

    Measured: Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration

  2. Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density

    Measured: Prior to therapy initiation and 12-15 months from registration

Secondary outcomes (2)

  1. Impact of Zometa (zoledronic acid) on time and site of relapse

    Measured: 5 years from registration

  2. Effect of treatment on quality of life in women undergoing treatment for LABC.

    Measured: Baseline and 12-15 months from registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2005 (estimated)
  2. Study startOct 2002
  3. Primary completionAug 2007
  4. Study completionMay 2011

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00242203
Sponsor's protocol ID
02-0788 / 201104272
Status last verified
Aug 2013
First submitted
17 Oct 2005
Last updated
13 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med. 1993 Jun;94(6):646-50. doi: 10.1016/0002-9343(93)90218-e. No abstract available.

    PubMed 8506892

  • Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997 Aug 18;103(2A):12S-17S; discussion 17S-19S. doi: 10.1016/s0002-9343(97)90022-x.

    PubMed 9302893

  • Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.

    PubMed 8970896

  • Pfeilschifter J, Diel IJ. Osteoporosis due to cancer treatment: pathogenesis and management. J Clin Oncol. 2000 Apr;18(7):1570-93. doi: 10.1200/JCO.2000.18.7.1570.

    PubMed 10735906

  • Cann CE, Martin MC, Genant HK, Jaffe RB. Decreased spinal mineral content in amenorrheic women. JAMA. 1984 Feb 3;251(5):626-9.

    PubMed 6690836

  • Shapiro CL, Manola J, Leboff M. Ovarian failure after adjuvant chemotherapy is associated with rapid bone loss in women with early-stage breast cancer. J Clin Oncol. 2001 Jul 15;19(14):3306-11. doi: 10.1200/JCO.2001.19.14.3306.

    PubMed 11454877

  • Young DM, Fioravanti JL, Olson HM, Prieur DJ. Chemical and morphologic alterations of rabbit bone induced by adriamycin. Calcif Tissue Res. 1975 Jul 4;18(1):47-63. doi: 10.1007/BF02546226.

    PubMed 1148891

  • Glackin CA, Murray EJ, Murray SS. Doxorubicin inhibits differentiation and enhances expression of the helix-loop-helix genes Id and mTwi in mouse osteoblastic cells. Biochem Int. 1992 Oct;28(1):67-75.

    PubMed 1280141

  • Reid IR. Glucocorticoid osteoporosis--mechanisms and management. Eur J Endocrinol. 1997 Sep;137(3):209-17. doi: 10.1530/eje.0.1370209.

    PubMed 9330580

  • Van Staa T, Abenhaim L, Cooper C: Use of cyclic etidronate and prevention of fractures. Bone 20:103s (abstract), 1997

  • Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996 Dec 7;348(9041):1535-41. doi: 10.1016/s0140-6736(96)07088-2.

    PubMed 8950879

  • McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY; Hip Intervention Program Study Group. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med. 2001 Feb 1;344(5):333-40. doi: 10.1056/NEJM200102013440503.

    PubMed 11172164

  • Reid IR, Brown JP, Burckhardt P, Horowitz Z, Richardson P, Trechsel U, Widmer A, Devogelaer JP, Kaufman JM, Jaeger P, Body JJ, Brandi ML, Broell J, Di Micco R, Genazzani AR, Felsenberg D, Happ J, Hooper MJ, Ittner J, Leb G, Mallmin H, Murray T, Ortolani S, Rubinacci A, Saaf M, Samsioe G, Verbruggen L, Meunier PJ. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med. 2002 Feb 28;346(9):653-61. doi: 10.1056/NEJMoa011807.

    PubMed 11870242

  • Saarto T, Blomqvist C, Valimaki M, Makela P, Sarna S, Elomaa I. Chemical castration induced by adjuvant cyclophosphamide, methotrexate, and fluorouracil chemotherapy causes rapid bone loss that is reduced by clodronate: a randomized study in premenopausal breast cancer patients. J Clin Oncol. 1997 Apr;15(4):1341-7. doi: 10.1200/JCO.1997.15.4.1341.

    PubMed 9193325

  • Delmas PD, Balena R, Confravreux E, Hardouin C, Hardy P, Bremond A. Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled study. J Clin Oncol. 1997 Mar;15(3):955-62. doi: 10.1200/JCO.1997.15.3.955.

    PubMed 9060533

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zometa, Epirubicin and Docetaxel in people with Breast Neoplasms, 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 6 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 13 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 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.

What does the primary outcome measure?

Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (time frame: Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration). 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 NCT00242203, which also lists 32 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 13 Aug 2013.

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