This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Gruppo Oncologico Nord Ovest – Mammella Intergruppo (GONO MIG). Clinical trials include:

1. Standard CEF versus accelerated CEF as adjuvant chemotherapy in node-positive or high-risk node-negative (T > 2 cm, age <35 years, G3, negative hormone receptors or high TL1 or S-phase) breast cancer. A phase III randomized trial. MIG-1

2. Epirubicin plus paclitaxel versus cyclophosphamide, epirubicin and 5-fluorouracil as adjuvant chemotherapy in node-positive breast cancer patients. A phase III randomized study. MIG-5

3. A phase III randomized study of sequential epidoxorubicin plus cyclophosp-amide followed by docetaxel (EC D) versus a combination of 5-fluorouracil, epidoxorubicin and cyclophosp-amide (FEC) as adjuvant treatment of node-negative early breast cancer patients.

4. A phase III randomized study of EC followed by paclitaxel versus FEC followed by paclitaxel, all given either every 3 or 2 weeks supported by pegfilgrastim, for node-positive breast cancer patients.

5. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with triptorelin versus control in young breast cancer patients. A randomized phase III multicenter study.

6. Letrozole adjuvant therapy duration (lead) study: standard versus long treatment. A phase III trial in post-menopausal women with early breast cancer.

This section provides current contact details and a list of recent or ongoing clinical trials that the Hellenic Breast Surgical Society (HBSS) participate in with other clinical trials groups, if applicable.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Breast Cancer Study Group (IBCSG). Clinical trials include:

1. CMF with or without prednisone for pre/perimenopausal patients with breast cancer and 1–3 positive nodes. Ludwig/IBCSG Trial I

2. CMF + prednisone combined with or without oophorectomy for pre/perimenopausal patients with breast cancer and 4 or more positive nodes. Ludwig/IBCSG Trial II

3. Adjuvant therapy for postmenopausal elderly patients (older than 65): observation versus prednisone tamoxifen. Ludwig/IBCSG Trial III

4. Adjuvant therapy for postmenopausal, 65 years or younger, node-positive breast cancer patients: observation versus prednisone + tamoxifen versus CMF + prednisone + tamoxifen. Ludwig/IBCSG Trial IV

5. Adjuvant perioperative chemotherapy. Ludwig/IBCSG Trial V

6. Adjuvant therapy in node-positive pre/perimenopausal breast cancer patients: CMF 3 versus 6 with or without reintroduction of chemotherapy. IBCSG Trial VI

7. Adjuvant chemotherapy in node-positive postmenopausal breast cancer patients: endocrine versus chemo-endocrine versus chemo-endocrine with delayed chemotherapy. IBCSG Trial VII

8. Adjuvant therapy in pre- and perimenopausal patients with node-negative breast cancer. Observation versus LH-RH analogue versus CMF versus CMF + LN-RH analogue. IBCSG Trial VIII

9. Adjuvant therapy in postmenopausal patients with node-negative breast cancer. Tamoxifen versus CMF followed by tamoxifen. IBCSG Trial IX

10. Surgical therapy with or without axillary node clearance for breast cancer in elderly patients who receive adjuvant therapy with tamoxifen. IBCSG Trial 10–93

11. Adjuvant therapy for premenopausal patients with node-positive breast cancer who are suitable for endocrine therapy alone. IBCSG Trial 11–93

12. Adjuvant therapy for post/perimenopausal patients with node-positive breast cancer who have estrogen-receptor-positive tumors. IBCSG Trial 12–93

13. Adjuvant therapy for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 13–93

14. Adjuvant therapy for post perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 14–93

15. High dose EC × 3 supported by PBSC versus EC/AC × 4 followed by CMF as adjuvant treatment for high-risk operable Stage II and Stage III breast cancer in premenopausal and young postmenopausal (<65 years) patients. IBCSG Trial 15–95

16. Adjuvant therapy for postmenopausal patients with operable breast cancer who have estrogen-receptor or progesterone-receptor-positive tumors. Tamoxifen versus letrozole versus tamoxifen followed by letrozole versus letrozole followed by tamoxifen. BIG 1–98 / IBCSG Trial 18–98

17. Maintenance chemotherapy in hormone non-responsive breast cancer: low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer. IBCSG Trial 22–00

18. A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node. IBCSG Trial 23–01

19. Suppression of Ovarian Function Trial (SOFT). A Phase III trial evaluating the role of ovarian function suppression (OFS) and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer. Tamoxifen versus OFS + tamoxifen versus OFS + exemestane. BIG 2–02/IBCSG Trial 24–02

20. Tamoxifen and Exemestane Trial (TEXT). A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer. Ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane. BIG 3–02/IBCSG Trial 25–02

21. Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE) A Phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.

22. Chemotherapy + OFS + tamoxifen/exemestane versus OFS + tamoxifen/ exemestane. BIG 4–02/IBCSG Trial 26–02

23. Chemotherapy for radically resected loco-regional relapse. BIG 1-02/IBCSG Trial 27–02/NSABP Protocol B-37

24. Chemotherapy adjuvant study for women at advanced Age (CASA) Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD) for women (age 66 years or older) with endocrine non-responsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”. BIG 1–05/IBCSG Trial 32–05

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Breast Cancer Intervention Study II Group (IBIS-II). Clinical trials include:

1. An international multi-centre study of anastrozole versus placebo in postmenopausal women at increased risk of breast cancer. IBIS-II (Prevention). BIG 05-02a

2. An international multi-centre study of tamoxifen versus anastrozole in postmenopausal women with ductal carcinoma in situ. IBIS-II. BIG 05-02b

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Collaborative Cancer Group (ICCG). Clinical trials include:

1. Epirubicin plus tamoxifen versus tamoxifen alone in postmenopausal node-positive primary breast cancer. C/4/87

2. Adjuvant cyclophosphamide methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in premenopausal node-positive primary breast cancer. (CMF/FEC N+). C/2/84

3. Adjuvant cyclophosphamide, methotrexate and 5-fluorouracil (CMF) versus 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in women with node-negative, poor-risk primary breast cancer. C/6/89

4. Adjuvant FEC50 versus FEC75 with or without the additional benefit of sequential hormone therapy (HT) in node-positive premenopausal primary breast cancer. C/9/91

5. High-dose therapy with PBCS support in primary breast cancer. C/10/92 – C/32/96

6. Randomized double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2–3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen. BIG 02-97/Study No. 96 OEXE 031-C/13/96

7. A multicentre-randomized trial of sequential epirubicin and docetaxel versus epirubicin in node-positive postmenopausal breast cancer patients. C/14/96

8. A phase III multicentre double-blind randomized trial of celecoxib versus placebo in primary breast cancer patients. An intergroup study from the International Collaborative Cancer Group and the German Breast Group (GBG). BIG 1-03 – ICCG/C/20/01 – GBG 27

This section provides current contact details and a list of recent or ongoing clinical trials that the ICORG the All-Ireland Clinical Oncology Research Group participate in with other clinical trials groups, if applicable.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU). Clinical trials include:

1. The NCRI Adjuvant Breast Cancer (ABC) trial. ISRCTN31514446

2. The UK randomized trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer. ISRCTN29941643

3. NCRI Standardisation of Breast Radiotherapy (START) trial. ISRCTN59368779

4. TACT: A randomized trial of standard anthracycline-based chemotherapy (fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF)) versus FEC followed by sequential docetaxel in women with early breast cancer. ISRCTN 79718493

5. SoFEA: Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on non-steroidal Aromatase inhibitors. ISRCTN: 44195747

6. TACT2: Trial of accelerated adjuvant chemotherapy with Capecitabine in early breast cancer. ISRCTN68068041

7. FAST trial: Prospective randomized clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control.

8. IMPORT low trial.

9. IMPORT high trial.

10. Adjuvant chemotherapy in older women (ACTION).

This section provides current contact details and a list of recent or ongoing clinical trials that the Italian Trials in Medical Oncology (ITMO) participate in with other clinical trials groups, if applicable.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Japan Breast Cancer Research Group (JBCRG). Clinical trials include:

1. Study of CEF-DOC as primary systemic chemotherapy for operable breast cancer.

2. Study of FEC-DOC100 as primary systemic chemotherapy for operable breast cancer.

3. DOC-FEC as primary systemic chemotherapy.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by North Central Cancer Treatment Group (NCCTG). Clinical trials include:

1. N9831: Phase III trial of doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel with or without trastuzumab as adjuvant treatment for women with HER2 over-expressing or amplified node positive or high-risk node negative breast cancer.

2. N063D, BIG 2–06: Phase III Trial of Trastuzumab and/or Lapatinib in Patients with HER2+ Breast Cancer

3. N0537: Phase II Trial of VEGF Trap in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and/or Taxane

4. N0531: Phase II trial of weekly NAB (nanoparticle albumin bound)-paclitaxel (nab-paclitaxel) (abraxane) in combination with gemcitabine in patients with metastatic breast cancer.

5. N0437: Phase II trial of CT-2103 (Xyotax) with capecitabine as first-line chemotherapy for patients with metastatic breast cancer.

6. N0436: Phase II trial of concurrent irinotecan plus cetuximab in patients with advanced breast cancer with prior anthracycline and/or taxane-containing therapy.

7. N0434: The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: a companion study to NCIC CTG MA 27

8. N0432: Phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer.

9. N0338: Phase II trial of docetaxel and carboplatin administered every 2 weeks as induction therapy for stage II or III breast cancer.

10. N0337: Phase II study of capecitabine in combination with vinorelbine and trastuzumab for the first- or second-line treatment of HER2 metastatic breast cancer.

11. N0336: Phase II trial of RAF kinase inhibitor BAY 43-9006 as single oral agent in patients with metastatic breast cancer previously exposed to anthracycline and/or taxane.

12. N0332: Phase II trial of weekly irinotecan and docetaxel in refractory metastatic breast cancer.

13. N0234: Phase II study of OSI-774 (Tarceva) and gemcitabine for patients with metastatic breast cancer.

14. N0032: Phase II trial of Faslodex in women with metastatic breast cancer and failure on aromatase inhibitor therapy.

15. N0031: A phase II study of topical ceramide lipids as treatment for cutaneous breast cancer.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG). Clinical trials include:

1. Double-blind randomized trial of tamoxifen versus placebo in patients with node-positive or high-risk node-negative (tumor ≥ 1 cm and either higher histological grade (poorly differentiated, or SBR grade III or MSBR grade V) or lymphatic/vascular invasion or both) breast cancer who have completed CMF, CEF or AC adjuvant chemotherapy. NCIC CTG Trial MA.12

2. A randomized trial of antiestrogen therapy versus combined antiestrogen and octreotide LAR therapy in the adjuvant treatment of breast cancer in postmenopausal women. NCIC CTG Trial MA.14

3. A phase III randomized double blind study of letrozole versus placebo in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17

4. NCIC CTG MA.17 Companion study (2): The influence of letrozole on bone mineral density in women with primary breast cancer completing five or more years of adjuvant tamoxifen. BIG 01-97/NCIC MA.17B

5. NCIC CTG MA.17 Companion study (1): The influence of letrozole on serum lipid concentrations in women with primary breast cancer who have completed 5 years of adjuvant tamoxifen. BIG 01-97/NCIC CTG MA.17L

6. NCIC CTG MA.17R A double blind re-randomization to letrozole or placebo for women completing 5 years of adjuvant letrozole in the MA.17 study.

7. A phase III study of regional radiation therapy in early breast cancer. NCIC CTG trial MA.20

8. A phase III adjuvant trial of sequenced EC + GCSF Taxol versus sequenced AC → Taxol versus CEF as therapy for premenopausal women and early postmenopausal women who have had potentially curative surgery for node positive or high-risk node negative breast cancer. NCIC CTG Trial MA.21

9. A phase I/II study of increasing doses of epirubicin and docetaxel + pegfilgrastim for locally advanced or inflammatory breast cancer. NCIC CTG Trial MA.22

10. A randomized phase III trial of exemestane versus anastrozole with or without celecoxib in postmenopausal women with receptor positive primary breast cancer. NCIC CTG Trial MA.27

11. A randomized feasibility study of letrozole in postmenopausal women at increased risk for development of breast cancer as evidenced by high breast density. NCIC CTG Trial MAP.1

12. A randomized study of the effect of exemestane (Aromasin) versus placebo on breast density in postmenopausal women at increased risk for development of breast cancer. NCIC CTG Trial: MAP.2

13. A phase III randomized study of exemestane versus placebo in postmenopausal women at increased risk of developing breast cancer. NCIC CTG Trial: MAP.3

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Surgical Adjuvant Breast and Bowel Project (NSABP). Clinical trials include:

1. NSABP B-35 – A clinical trial comparing anastrozole with tamoxifen in postmenopausal patients with ductal carcinoma in situ (DCIS) undergoing lumpectomy with radiation therapy.

2. NSABP B-36 – A clinical trial of adjuvant therapy comparing six cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) to four cycles of adriamycin and cyclophosphamide (AC) in patients with node-negative breast cancer.

3. NSABP B-38 – A phase III, adjuvant trial comparing three chemotherapy regimens in women with node-positive breast cancer: docetaxel/doxorubicin/cyclophosphamide (TAC); dose-dense (DD) doxorubicin/cyclophosphamide followed by DD paclitaxel (DD AC→P): DD AC followed by DD paclitaxel plus gemcitabine (DD AC→PG).

4. NSABP B-39 – A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Radiation therapy Oncology group (RTOG). Clinical trials include:

1. RTOG 9804: Phase III trial of observation ± tamoxifen versus RT ± tamoxifen for good risk duct carcinoma in-situ(DCIS) of the female breast.

2. NSABP B-39/RTOG 0413: A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer.

3. A phase II trial to evaluate three dimensional conformal radiation therapy (3D-RT) confined to the region of the lumpectomy cavity for stage I and II breast carcinoma.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Swiss Group for Clinical Cancer Research (SAKK) – Breast Cancer Project Group. Clinical trials include:

1. Randomized phase III trial of Herceptin followed by chemotherapy plus Herceptin versus the combination of Herceptin and chemotherapy as palliative treatment in patients with HER2-overexpressing advanced/metastatic breast cancer. Protocol SAKK 22/99

2. Trastuzumab monotherapy followed by the combination of trastuzumab and letrozole in post-menopausal women with ER-positive, HER-2 positive advanced breast cancer resistant to a nonsteroidal aromatase inhibitor. A multicenter two-step phase II trial Protocol SAKK 23/03

3. Phase I–II trial of capecitabine and vinorelbine in elderly patients ( 65 years) with metastatic breast cancer with and without bone involvement. Protocol SAKK 25/99

4. Phase I/II trial of capecitabine with weekly paclitaxel for advanced breast cancer. Protocol SAKK 26/00

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Scandinavian Breast Group (SBG). Clinical trials include:

1. High-dose chemotherapy + autologous stem cell transplantation compared with dose escalating chemotherapy in breast cancer with poor prognosis ≥ 8 positive lymph nodes or ≥ 5 lymph nodes combined with R-combined with either G II–III or high S-phase. A randomized study. SBG 9401

2. Standard CEF-60 versus tailored CEF in high-risk primary breast cancer. SBG CEF-60, SBG 2000-1

3. HABITS – Hormonal replacement therapy after breast cancer diagnosis – is it safe? BIG 03-97

4. A phase II study continuing into a randomized phase III study comparison of safety, feasibility and efficacy of: dose dense and tailored and dose escalated epirubicin + cyclophosphamide followed by docetaxel (dEC→T) or dose dense epirubicin + cyclophosphamide followed by docetaxel (EC→T) or docetaxel + doxorubicin + cyclophosphamide (TAC) in lymph node positive breast cancer patients. SBG 2004-1 STUDY

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Grupo Espanol de Estudio Tratamiento y otras Estrategias Experimentales en Tumores Solidos (SOLTI). Clinical trials include:

1. A phase III randomized, controlled trial of myocet, trastuzumab and paclitaxel versus trastuzumab and paclitaxel for first line therapy of metastatic breast cancer.

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Southwest Oncology Group (SWOG). Clinical trials include:

1. Docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER-2 positive, stage IV breast cancer. S0215

2. Phase III trial of continuous schedule AC + G versus q 2-week schedule AC, followed by paclitaxel given either q 2 weeks or weekly for 12 weeks as post-operative adjuvant therapy in node-positive or high-risk node-negative breast cancer. S0221

3. Phase III randomized trial of anastrozole versus anastrozole and fulves-trant as first line therapy for postmenopausal women with metastatic breast cancer. S0226

4. Phase III trial of LHRH analog administration during chemotherapy to reduce ovarian failure following chemotherapy in early stage, hormone-receptor negative breast cancer. S0230

5. Phase III trial of bisphosphonates as adjuvant therapy for primary breast cancer. S0307

6. Phase II trial of simple oral therapy (continuous oral cyclophosphamide and capecitabine) in patients with metastatic breast cancer. S0430

7. A phase II study of goserelin plus anastrozole for the treatment of male patients with hormone-receptor positive metastatic or recurrent breast cancer. S0511

8. Randomized placebo-controlled biomarker modulation trial using celecoxib in premenopausal women at high risk for breast cancer. Phase IIb. S0300

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by West Midlands Breast Group (WMBG). Clinical trials include:

1. aTTom – adjuvant Tamoxifen Treatment – offer more?

2. Sequencing of chemotherapy and radiotherapy in adjuvant breast cancer. SECRAB

3. A phase III randomized trial of gemcitabine in paclitaxel-containing, epirubicin-based, adjuvant chemotherapy for women with early stage breast cancer. tAnGo

4. Tamoxifen and Exemestane Adjuvant Multicentre trial TEAM

5. Neoadjuvant trial of preoperative exemestane or letrozole ± celecoxib in the treatment of ER positive postmenopausal early breast cancer NEO-EXCEL

6. A neoadjuvant study of sequential epirubicin + cyclophosphamide and paclitaxel ± gemcitabine in the treatment of high risk early breast cancer with molecular profiling, proteomics and candidate gene analysis. Neo-tAnGo

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by West German Study Group (WSG). Clinical trials include:

1. WSG and AGO-Mamma Intergroup Study: Randomized phase III trial of EC-Doc: adjuvant chemotherapy of breast carcinoma with 1–3 positive lymph nodes. (AM02)

2. WSG Study: Randomized phase III trial of adjuvant CEF/TAC chemotherapy +/− Darbepoetin alfa for patients with primary breast cancer and more than 3 positive axillary lymph nodes. ARA Plus (AM03)

3. ICE – Study: Ibandronate with or without capecitabine in elderly patients with early breast cancer. BIG 4-04 / GBG 32. (see also description under GBG)

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Yorkshire Breast Cancer Research Group (YBCRG). Clinical trials include:

1. Does adjuvant zoledronic acid reduce recurrence in patients with high risk localized breast cancer? – The AZURE Trial. BIG 1-04

2. Cost-effective use of BISphosphonates in metastatic bone disease: A comparison of bone MARKer directed zoledronic acid therapy to a standard schedule – The BISMARK Trial.