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Specimens available for research & TBCI Correlative Sciences Committee
Specimen collection guidelines for breast cancer Group trials
Active trials
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Members only (non-NCI site)
The Breast Cancer Intergroup of North America (TBCI) is a network of NCI-sponsored Clinical Trials Cooperative Groups conducting research in breast cancer.
Six NCI-supported Clinical Trials Cooperative Groups make up TBCI:
While not a part of TBCI, a number of other Groups collaborate with TBCI when it is believed such a pooling of resources will help to answer an important research question more efficiently and effectively. These Groups include the following:
TBCI is chaired by William Wood, M.D., Chairman of the Department of Surgery at the Emory University School of Medicine in Atlanta.
JoAnne Zujewski, M.D., Senior Investigator in the Clinical Investigations Branch at NCI-CTEP, serves as NCI liaison to TBCI.
Making up the core of TBCI are the chairs and vice-chairs of the breast committees of TBCI-member Groups:
Breast committee chairs
Kelly Hunt, M.D. (ACOSOG)
Clifford Hudis, M.D. (Co-Chair, CALGB)
Eric Winer, M.D. (Co-Chair, CALGB)
George Sledge, M.D. (ECOG)
Edith Perez, M.D. (NCCTG)
Karen Gelmon, M.D. (NCIC CTG)
Gabriel Hortobagyi, M.D., F.A.C.P. (SWOG)
Breast committee vice-chairs
Marilyn Leitch, M.D., FACS (ACOSOG)
Rache Simmons, M.D. (ACOSOG)
Pat Whitworth, M.D. (ACOSOG)
Matthew Ellis, M.B., Ph.D. (CALGB)
Joseph Sparano, M.D. (ECOG)
Timothy Whelan, BM, BCh, MSc (NCIC CTG)
Julie Gralow, M.D. (SWOG)
TBCI is dedicated to the study and advancement of breast cancer therapies through Intergroup collaboration on NCI-sponsored clinical trials. This mission includes promoting investigation into biologic correlates in breast cancer through performance of correlative and companion studies associated with these trials.
TBCI Chair:
William Wood, M.D.
Chairman, Department of Surgery, Emory University School of Medicine
Phone: 404-727-5800
Email: William_Wood@emoryhealthcare.org
NCI liaison to TBCI:
JoAnne Zujewski, M.D.
Senior Investigator, NCI-CTEP
Phone: 301-496-2522
Email: ZujewskJ@mail.nih.gov
Active TBCI clinical trials Back to top
* denotes endorsing Groups as reported by the CTSU (as of 12/4/06
for most trials).
Sorted by Protocol number
| Protocol number |
Participating Groups |
Title |
Study arms |
Protocol Description (PDQ) |
Specimen submission specified by protocol |
Planned accrual |
Year activated |
P.I. |
| ACOSOG-Z1031 |
ACOSOG, CALGB
|
"A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen and/or Progesterone Receptor Positive Breast Cancer"
|
Pre-surgery exemestane (25 mg/day) - 16-18 wks
vs.
Pre-surgery letrozole (2.5 mg/day) - 16-18 wks
vs.
Pre-surgery anastrozole (1 mg/day) - 16-18 wks
|
Protocol Description (PDQ) |
2 core biopsies frozen in separate OCT blocks and 2 formalin-fixed core biopsies at baseline and surgery (option for 1-month samples as well; if disease progression, biopsies prior to chemo)
Serum, plasma, and anti-coagulated whole blood at baseline and 16-week visit pre-surgery |
375 |
2006 |
Matthew Ellis, M.B., Ph.D., FRCP |
| ACOSOG Z1041 |
ACOSOG
|
"A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with Palpable and Operable Breast Cancer"
|
Arm 1: Preoperative FEC-75 (Q3W x 4) --> Paclitaxel (Q1W x 12) + Trastuzumab (Q1W x 12) --> Surgery --> Trastuzumab (Q3W through 52 wks from 1st preop dose)
Arm 2: Preoperative Paclitaxel (Q1W x 12) + Trastuzumab (Q1W x 12) --> FEC-75 (Q3W x 4) + Trastuzumab (Q1W x 12) --> Surgery --> Trastuzumab (Q3W through 52 wks from 1st preop dose)
|
Protocol Description (PDQ) |
Pre-treatment:
1 core biopsy tissue in RNA later
1 core biopsy tissue in formalin
2 core biopsy tissue snap frozen in OTC
Following Definitive Surgery:
4 unstained sections from each of the 10-15 blocks from breast tumor
4 unstrained sections from residual tumor
Blood at multiple time points
|
270 |
2007 |
Dr. Aman U. Buzdar |
| CALGB-40101 |
CALGB (Lead), ACOSOG, *ECOG, GOG, *NCCTG, NCIC CTG, NSABP, RTOG, *SWOG
|
Cyclophosphamide and Doxorubicin (CA) (4 vs. 6 Cycles) Versus
Paclitaxel (4 vs. 6 Cycles) as Adjuvant Therapy for Breast Cancer in
Women with 0-3 Positive Axillary Lymph Nodes: A 2X2 Factorial Phase
III Randomized Study
|
Arm I: AC Q2W x 4
Arm II: AC Q2W x 6.
Arm III: paclitaxel Q2W x 4
Arm IV: paclitaxel Q2W x 6
Lumpectomy pts then undergo RT.
Mastectomy pts undergo RT at physician discretion.
|
Protocol Description (PDQ) |
Paraffin block of tumor; blood, drawn generally prior to treatment |
4,646 |
2002 |
Dr. Lawrence Shulman |
| CALGB-40302 |
CALGB (Lead), *SWOG |
Endocrine Therapy with or without Inhibition of EGF and HER2 Growth Factor
Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer
|
Arm I: Lapatinib (oral) daily + fulvestrant (IM)
Arm II: Placebo (oral) daily + fulvestrant (IM)
|
Protocol Description (PDQ) |
Paraffin block(s) of tumor, including block of metastatic tumor, and whole blood for serum are requested |
324 |
2006 |
Dr. Harold J. Burstein |
| CALGB-40503 |
CALGB (Lead), *ECOG |
Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer
|
Endocrine therapy daily (tamoxifen or letrozole) + bevacizumab Q3W
vs.
Endocrine therapy daily (tamoxifen or letrozole) + placebo Q3W
(If pre-menopausal: Ovarian suppression with monthly LH-RH agonist)
|
Protocol Description (PDQ) |
Paraffin block of primary tumor, Blood. (With banking of specimen remaining after trial-related correlative studies for future research.)
|
442 |
2008 |
Dr. Maura Dickler |
| ECOG E1105 |
ECOG
NCCTG
CALGB
SWOG
|
A Randomized Phase III Double Blind Placebo-Controlled Trial of First Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer
|
Arm A
Trastuzumb and paxlitaxel+/- Carboplatin q7d X 4) plus placebo (q14d X 6)
Followed by trastuzumab
+ placebo (q21d)
Arm B
Trastuzumb and paxlitaxel+/- Carboplatin q7d X 4) plus
|
Protocol Description (PDQ) |
One block containing primary tumor
At Baseline, Day 1 Cycle 2 and Day 1 Cycle 4:
Serum
Whole Blood
Urine
Peripheral Blood
|
489 |
2007 |
Dr. Ingrid Mayer |
| ECOG E5103 |
ECOG
NCCTG
CALGB
|
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
|
Arm A
AC + placebo (q21d X4) followed by paxlitaxel (q7d X12) + Placebo
Arm B
AC + Bev (q21d X 4) followed by paxlitaxel (q7d) + Bev (q21d X 4)
Arm C
AC + Bev (q21d X 4) followed by paxlitaxel (q7d) + Bev (q21d X 4) followed by Bev (q21d X 10)
|
Protocol Description (PDQ) |
All Samples will be requested at baseline, prior to treatment:
Serum, 6-10mL, No anticoagulants
Plasma, one 10mL tube or two 5mL tubes
1 Block primary tumor
1 Block lymph node positive tumor
|
4950 |
2007 |
Dr. Kathy Miller |
| NCCTG N063D |
SWOG
NCIC CTG
ECOG
CALGB
|
ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer
|
Design 1
Arm I
trastuzumab (q21d X 52)
Arm II
lapatinib oral daily X 365
Arm III
Trastuzumab IV X12 followed by lapatinib oral daily X 34)
lapatinib oral daily plus trastuzumab q21d X 52)
Design 2
Arm 1
Paxlitaxel q7d X 12) + Trastuzumab (q7d X 12) followed by Trastuzumab q21d)
Arm II
Paxlitaxel (q7d X 12) + lapatinib oral daily X 52
Arm III
Paxlitaxel (q7d X 12) +
Trastuzumab (q7d X 12)
Lapatinib X 34
Arm IV
Paxlitaxel (q7dX 12) +
Trastuzumab (q7d X 12) +
Lapatinib oral daily followed by lapatinib + trastuzumab
|
Protocol Description (PDQ) |
A recommended 2 Frozen tissue cores will be taken at the point of surgery or from the first biopsy
Two formalin-fixed, paraffin-embedded (FFPE) blocks, one tumor (preferably the same block
used for the original diagnosis of breast cancer) and one normal breast tissue, and representative
H & E
Whole blood and peripheral samples will be requested at baseline and at the end of years 1, 2, and 5.
|
8,000 |
2008 |
Dr. Edith A Perez
Dr.
Martine J Piccart
|
| NCIC-MA.17R |
NCIC CTG (Lead), BIG, CALGB, ECOG, EORTC, NCCTG, SWOG |
Letrozole or placebo for women previously diagnosed with primary
breast cancer completing five years of adjuvant aromatase inhibitor
either as initial therapy or after tamoxifen (including those in the
MA.17 study)
|
Arm I: 5 years letrozole (following 4.5 - 6 years of aromatase
inhibitor* therapy)
Arm II: 5 years placebo (following 4.5 - 6 years of aromatase
inhibitor* therapy)
*letrozole, anastrozole or exemestane
|
|
Paraffin block of tumor (see NCIC-JMA17, below); baseline blood |
1,800 |
2004 |
Dr. Paul Goss |
| NCIC-MA.27 |
NCIC CTG (Lead), ACOSOG, *CALGB, *ECOG, GOG, *NCCTG, NSABP, RTOG, *SWOG
|
A Randomized Phase III Trial of Exemestane Versus Anastrozole in
Postmenopausal Women with Receptor Positive Primary Breast Cancer |
Arm I: Oral exemestane for 5 years
Arm II: Oral anastrozole for 5 years
|
Protocol Description (PDQ) |
Paraffin block of tumor; frozen tumor (virtual bank); blood at baseline and 6 months |
6,840 |
2003 |
Dr. Paul Goss |
| PACCT-1 |
ECOG (Lead), *ACOSOG, *CALGB, *NCCTG, *NCIC CTG, *NSABP, RTOG, *SWOG |
(TAILORx trial) Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial |
Recurrence Score < 11:
hormonal therapy
Recurrence Score 11-25 (Randomized Arm):
hormonal therapy
vs.
chemotherapy --> hormonal therapy
Recurrence Score > 25:
chemotherapy --> hormonal therapy
|
Protocol Description (PDQ) |
paraffin block of primary tumor, blood, plasma |
10,046 |
2006 |
Dr. Joseph Sparano |
| S0221 |
SWOG (Lead), ACOSOG, *CALGB, *ECOG, *NCCTG, *NCIC CTG, NSABP, RTOG |
Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer |
Arm I: AC + pegfilgrastim Q2W x 6 followed by paclitaxel + pegfilgrastim Q2W x 6
Arm II: AC + filgrastim (G-CSF) weekly x 15 followed by paclitaxel + pegfilgrastim Q2W x 6
Arm III: AC + pegfilgrastim Q2W x 6 followed by paclitaxel weekly x 12
Arm IV: AC + filgrastim (G-CSF) weekly x 15 followed by paclitaxel weekly x 12
ER+/PR+ pts start hormonal therapy w/in 28 days completion of adjuv chemo or RT
|
Protocol Description (PDQ) |
Paraffin block of primary tumor (if not possible, block punch + 25 five-micron unstained slide sections); baseline blood, serum
|
3,250 |
2003 |
Dr. G. Thomas Budd |
| S0226 |
SWOG (Lead), CALGB, ECOG, NCCTG, *NCIC CTG, NSABP |
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer |
Arm I: anastrozole
Arm II: anastrozole + fulvestrant
|
Protocol Description (PDQ) |
Paraffin block of primary tumor (if not possible, block punch + 25 five-micron unstained slide sections); baseline and serial serum in 50 patients on each arm
|
690 |
2004 |
Dr. Rita Mehta |
| S0307 |
SWOG (Lead), ACOSOG, *CALGB, *ECOG, *NCCTG, *NCIC CTG, *NSABP |
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary
Breast Cancer |
Arm I: Zoledronate IV for 3 years (monthly for 6 mos, then every 3 mos)
Arm II: Oral clodronate for 3 years (daily)
Arm III: Oral ibandronate for 3 years (daily)
|
Protocol Description (PDQ) |
Paraffin block of primary tumor (if not possible, block punch + 25 five-micron unstained slide sections); baseline serum |
6,000 |
2005 |
Dr. Julie Gralow |
| S0500 |
SWOG, CALGB |
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell (CTC) Levels at First Follow-Up Assessment
|
Change in therapy vs. No change in therapy, based on CTC levels
|
Protocol Description (PDQ) |
(encouraged) Serum from patients with > 5 CTC/7.5 mL blood or higher at initial screening, on Days 22, 50 or 57, 85, 176, and 270.
|
120 randomized, 500 screened |
2006 |
Jeffrey Smerage, M.D., Ph.D. |
Closed TBCI clinical trials Back to top
| Protocol number |
Participating Groups |
Title |
Study arms |
Protocol Description (PDQ) |
Specimens available for research |
Years Active |
Total patient accrual |
P.I. |
| C9741 |
CALGB (Lead), ECOG, NCCTG, SWOG |
Phase III Randomized Study of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed By Paclitaxel at 14 and 21 Day Intervals in Women With Node Positive Stage II or IIIA Breast Cancer |
Arm I: Sequential A, paclitaxel, C, Q3W
Arm II: Sequential A+ G-CSF, paclitaxel + G-CSF, C + G-CSF Q2W
Arm III: Concurrent AC followed by paclitaxel Q3W
Arm IV: Concurrent AC + G-CSF followed by paclitaxel + G-CSF Q2W
Patients receive tamoxifen and RT post-chemo.
|
Protocol Description (PDQ) |
Specimens available for research |
1997-1999 |
2,005 |
Dr. Marc Citron |
| CALGB-49907 |
CALGB (Lead), ACOSOG, *ECOG, GOG, *NCCTG, *NCIC CTG, NSABP, RTOG, *SWOG
|
A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens,
Cyclophosphamide, Methotrexate and Fluorouracil -(CMF) or Doxorubicin and
Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older
with Node Positive or Node-Negative Breast Cancer |
Arm I, AC Q3W x 4 (pts w/normal LVEF) or CMF Q4W x 6
Arm II: Capecitabine Q3W x 6
Following treatment, ER+/PR+ pts receive tamoxifen or aromatase inhibitor for 5 years, and breast conservation surgery pts undergo RT
|
Protocol Description (PDQ) |
Paraffin block of tumor |
2001-2006 |
623 as of late Nov 2006 |
Dr. Hyman Muss |
| CALGB-8944 (INT-0112) |
CALGB (Lead), ECOG |
Phase II Combined Modality Treatment of Patients with Stage III Adenocarcinoma of the Breast: Intensive ADR Chemotherapy Followed by Definitive Surgery, CMF, and Radiotherapy |
Sequential Adriamycin, Surgery, CMF, Radiotherapy, and, for ER/PgR+,
Tamoxifen
(non-randomized)
|
Protocol Description (PDQ) |
|
1990-1992 |
113 |
Dr. David Duggan |
| CALGB-9082 (INT-0163) |
CALGB (Lead), SWOG, NCIC CTG |
Phase III Randomized Comparison of High-Dose Chemotherapy with Autologous Marrow and Peripheral Stem Cell Support vs Standard-Dose Chemotherapy Following Adjuvant Chemotherapy in Women with Stage II/IIIA Breast Cancer with at Least 10 Positive Axillary Nodes |
Arm I: Standard-dose chemo
Arm II: High-dose chemo followed by BMT and PBSCT
|
Protocol Description (PDQ) |
|
1991-1998 |
1,036 |
Dr. William Peters |
| CALGB-9343 |
CALGB (Lead), ECOG, RTOG |
Phase III Randomized Study of Adjuvant Tamoxifen with vs without Radiotherapy Following Lumpectomy for Carcinoma of the Breast No Greater Than 2 cm with Clinically Negative Axillary Nodes in Women Age 70 and Over |
Arm I: Tamoxifen
Arm II: Tamoxifen + Radiotherapy
|
Protocol Description (PDQ) |
Specimens available for research |
1994-1999 |
647 |
Dr. Kevin Hughes |
| CALGB-9344 (INT-0148) |
CALGB (Lead), ECOG, NCCTG, SWOG |
Phase III Randomized Study of Adjuvant CA (Cyclophosphamide/ Doxorubicin) Comparing Standard- vs Intermediate- vs High-Dose Doxorubicin, with vs without Subsequent Paclitaxel, in Women with Node-Positive Breast Cancer |
Arm I: Standard-dose doxorubicin
Arm II: Medium-dose doxorubicin
Arm III: High-dose doxorubicin
Arm IV: Standard-dose doxorubicin followed by paclitaxel
Arm V: Medium-dose doxorubicin followed by paclitaxel
Arm VI: High-dose doxorubicin followed by paclitaxel
|
Protocol Description (PDQ) |
Specimens available for research |
1994-1997 |
3,170 |
Dr. Isaac Henderson |
| E1193 |
ECOG (Lead), NCCTG, SWOG |
Phase II/III Randomized Trial of doxorubicin vs paclitaxel vs doxorubicin/paclitaxel/G-CSF in Patients with Metastatic Breast Cancer |
Arm A: Doxorubicin
Arm B: Paclitaxel
Arm C: Doxorubicin/ Paclitaxel/G-CSF
|
Protocol Description (PDQ) |
|
1993-1995 |
736 |
Dr. George Sledge |
| E1199 |
ECOG (Lead), CALGB, NCCTG, SWOG |
Phase III Randomized Study of Doxorubicin and Cyclophosphamide Followed By Paclitaxel or Docetaxel in Women With Node-Positive or High-Risk Node-Negative Stage II or IIIA Breast Cancer |
Arm I: AC followed by paclitaxel 3 hrs Q3W X4
Arm II: AC followed by paclitaxel 1 hr Q1W X12
Arm III: AC followed by docetaxel 1 hr Q3W X4
Arm IV: AC followed by docetaxel 1 hr Q1W X12
|
Protocol Description (PDQ) |
Specimens available for research |
1999-2002 |
5,052 |
Dr. Joseph Sparano |
| E2100 |
ECOG (Lead), CALGB, GOG, NCIC CTG, NSABP, NCCTG, RTOG, SWOG |
Phase III Randomized Study of Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer |
Arm I: Paclitaxel followed by bevacizumab
Arm II: Paclitaxel
|
Protocol Description (PDQ) |
Specimens available for research |
2002-2004 |
722 |
Dr. Kathy Miller |
| E2190 (INT-0121) |
ECOG (Lead), CALGB, SWOG |
Phase III Randomized Study of Adjuvant CAF (Cyclophosphamide/ Doxorubicin/Fluorouracil) vs Adjuvant CAF Followed by Intensification with High-Dose Cyclophosphamide/Thiotepa plus Autologous Stem Cell Rescue in Women with Stage II/III Breast Cancer At High Risk of Recurrence |
Arm I: CAF
Arm II: CAF followed by cyclophos./thiotepa + BM or PBSC rescue
|
Protocol Description (PDQ) |
Specimens available for research |
1991-1998 |
540 |
Dr. Martin Tallman |
| E2197 |
ECOG (Lead), CALGB, NCCTG, SWOG |
Phase III Randomized Study of Doxorubicin/Docetaxel versus Doxorubicin/ Cyclophosphamide as Adjuvant Treatment for Node Positive or High Risk Node Negative Breast Cancer |
Arm I: Doxorubicin + Docetaxel
Arm II: Doxorubicin + Cyclophosphamide
|
Protocol Description (PDQ) |
Specimens available for research |
1998-2000 |
2,952 |
Dr. Lori Goldstein |
| E3193 (INT-0142) |
ECOG (Lead Group), CALGB, NCCTG, SWOG |
Phase III Randomized Study of Adjuvant Tamoxifen with vs without Ovarian Ablation in Premenopausal Women with Axillary Node-Negative Receptor-Positive Breast Cancer 3 cm or Less in Diameter |
Arm I: Tamoxifen
Arm II: Tamoxifen + Ovarian albation
|
Protocol Description (PDQ) |
Specimens available for research |
1994-1997 |
345 |
Dr. Nicholas Robert |
| E5188 (INT-0101) |
ECOG (Lead), CALGB, SWOG |
Phase III Randomized Comparison of Adjuvant Therapies in Premenopausal Women with Resected Node-Positive Hormone Receptor-Positive Adenocarcinoma of the Breast: CAF vs CAF Followed by Zoladex vs CAF Followed by Zoladex/Tamoxifen |
Arm I: CAF
Arm II: CAF followed by Goserelin
Arm III: CAF followed by Goserelin + Tamoxifen
|
Protocol Description (PDQ) |
Specimens available for research |
1989-1994 |
1,536 |
Dr. Nancy Davidson |
| E5194 |
ECOG (Lead), NCCTG |
Screening Study Following Local Excision in Selected Patients with Ductal Carcinoma in Situ (DCIS) of the Breast |
(screening following local excision) |
Protocol Description (PDQ) |
Specimens available for research |
1997-2002 |
711 |
Dr. Lorie Hughes |
| E-EB193 (INT-0151) |
ECOG (Lead), CALGB, NCCTG, SWOG |
Phase III Randomized Study of Adjuvant Tamoxifen/Fenretinide vs Tamoxifen/Placebo in Postmenopausal Women with Receptor-Positive Breast Cancer |
Arm I: Tamoxifen/fenretinide
Arm II: Tamoxifen/placebo
|
Protocol Description (PDQ) |
Specimens available for research |
1995-1999 |
426 |
Dr. Melody Cobleigh |
| E-PBT01 |
ECOG (Lead), NCCTG, PBTG, SWOG |
Phase III Randomized Comparison of Conventional CMF Maintenance vs High-Dose Combination Chemotherapy plus Autologous Bone Marrow and Peripheral Stem Cell Rescue in Women with Metastatic Breast Cancer Responding to Conventional Induction Chemotherapy |
Induction:
CAF, or CMF +/- prednisone
Post-induction:
Arm I: high-dose cyclophosphamide, thiotepa, and carboplatin followed by rescue with autologous
bone marrow and/or peripheral stem cells + GM-CSF
Arm II: standard-dose CMF
|
Protocol Description (PDQ) |
|
1994-1997 |
553 |
Dr. Edward Stadtmauer |
| EST-1180 (INT-0011) |
ECOG (Lead), CALGB, SWOG |
Phase III Adjuvant Chemotherapy with CMFP (CTX/MTX/5-FU/PRED) and Evaluation of Biological Parameters in Node-Negative Operable Female Breast Cancer |
Arm I: CMFP (Cyclophosphamide, Methotrexate, 5-Fluorouracil,
Prednisone)
Arm II: Observation
|
Protocol Description (PDQ) |
Specimens available for research |
1981-1988 |
1,224 |
Dr. Edward Mansour |
| EST-3189 (INT-0108) |
ECOG (Lead), SWOG |
Phase III Randomized Comparison of CAF vs a 16-Week Multi-Drug Regimen (Cyclophosphamide, Doxorubicin, Vincristine, Methotrexate, 5-Fluorouracil) as Adjuvant Therapy in Node-Positive Patients with Receptor-Negative Breast Cancer |
Arm I: CAF Cyclophosphamide, Doxorubicin, 5-Fluorouracil
Arm II:
Cyclophosphamide, Doxorubicin, Vincristine, Methotrexate, 5-Fluorouracil +
Leucovorin Rescue
Regimen A: Radiotherapy (less than total mastectomy)
|
Protocol Description (PDQ) |
|
1989-1993 |
646 |
Dr. John Fetting |
| N9831 |
NCCTG (Lead), CALGB, ECOG, NCIC CTG, SWOG |
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel with or without Trastuzumab as Adjuvant Treatment for Women with HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer |
Arm I: AC, followed by paclitaxel
Arm II: AC, followed by paclitaxel, followed by trastuzumab
Arm III: AC, followed by paclitaxel, followed by paclitaxel and trastuzumab, followed by trastuzumab
All receptor+ pts receive tamoxifen or A.I.; selected pts may undergo RT
|
Protocol Description (PDQ) |
Specimens available for research |
2000 |
3,505 |
Dr. Edith Perez |
| NCIC-JMA17 |
NCIC CTG (Lead), BIG, CALGB, ECOG, EORTC, NCCTG, SWOG |
Phase III Randomized Study of Letrozole Versus Placebo in Postmenopausal Women With Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen |
Arm I: Letrozole (following ≥ 5 yrs tamoxifen)
Arm II: Placebo (following ≥ 5 yrs tamoxifen)
|
Protocol Description (PDQ) |
Specimens available for research |
1998-2002 |
5,187 |
Dr. Paul Goss |
| NCIC-MA.20 |
NCIC CTG (Lead), *CALGB, ECOG, *NCCTG, *NSABP, *RTOG, *SWOG |
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer |
Arm I: standard breast radiotherapy (RT) alone 5 days/week x 5
Arm II: breast + regional RT 5 days/week x 5
RT initiated w/in 8 weeks following adjuvant chemo completion unless concurrent, or w/in 16 weeks following last surgery for hormonal-therapy-alone pts.
|
Protocol Description (PDQ) |
Paraffin block of tumor |
2002-2007 |
1,829 |
Dr. Timothy Whelan |
| NCIC-MA.21 |
NCIC CTG (Lead), CALGB, ECOG, NCCTG, NSABP, RTOG, SWOG |
A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel 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 |
Arm I: CEF Q4W x 6
Arm II: EC + G-CSF Q2W x 6 + epoetin alpha weekly
followed by paclitaxel + G-CSF Q3W x 4 + epoetin alpha weekly
Arm III: AC Q3W x 4 followed by paclitaxel Q3W x 4
ER+/PR+ pts receive tamoxifen or anastrozole for 5 years after chemo completion
|
Protocol Description (PDQ) |
Specimens available for research |
2002 |
2,104 |
Dr. Margot Joy Burnell |
| S9623 |
SWOG (Lead), CALGB, ECOG, NCCTG |
Phase III Randomized Study of Intensive Sequential Doxorubicin, Paclitaxel, and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed By STAMP I or STAMP V Combination Chemotherapy With Autologous Stem Cell Rescue in Women With Primary Breast Cancer and At Least 4 Involved Axillary Lymph Nodes |
Arm I: Doxorubicin, paclitaxel, cyclophosphamide, + G-CSF
Arm II: Doxorubicin, cyclophosphamide + harvest of autologous bone marrow or PBSC; followed by STAMP I (cyclophosphamide, cisplatin, carmustine) or STAMP V(cyclophosphamide, carboplatin, thiotepa), followed by transplantation
tamoxifen daily and locoregional radiotherapy
|
Protocol Description (PDQ) |
Specimens available for research |
1996-2001 |
602 |
Dr. Scott Bearman |
| S9927 |
SWOG (Lead), ACOSOG, CALGB, ECOG, NCCTG, NCIC CTG, NSABP, RTOG |
Phase III Randomized Study of Radiotherapy After Mastectomy and Adjuvant Chemotherapy and/or Hormonal Therapy in Women With Stage II Breast Cancer With One to Three Positive Nodes |
Arm I: Radiotherapy
Arm II: Observation
|
Protocol Description (PDQ) |
Specimens available for research |
2000-2003 |
98 |
Dr. Lori Pierce |
| SWOG-8692 (INT-0075) |
SWOG (Lead), ECOG, NCCTG |
Phase III Randomized Comparison of Surgical Oophorectomy vs Medical Oophorectomy with Goserelin in Premenopausal Women with Metastatic, ER-Positive or PR-Positive Carcinoma of the Breast |
Arm I: oophorectomy
Arm II: goserelin, with selected
patients receiving oophorectomy
|
Protocol Description (PDQ) |
|
1987-1995 |
138 |
Dr. William Dalton |
| SWOG-8814 (INT-0100) |
SWOG (Lead), CALGB, ECOG, NCIC CTG, NCCTG |
Phase III Randomized Comparison of Adjuvant Therapy with Tamoxifen vs CAF plus Concurrent or Delayed Tamoxifen in Postmenopausal Women with Node- and Receptor-Positive Breast Cancer |
Arm I: Tamoxifen
Arm II: CAF followed by tamoxifen
Arm III: CAF plus concurrent tamoxifen
Regimen A: Radiotherapy (lumpectomy)
Regimen B: Radiotherapy (selected mastectomy pts)
|
Protocol Description (PDQ) |
Specimens available for research |
1989-1995 |
1,558 |
Dr. Kathy Albain |
| SWOG-8897 (INT-0102) |
SWOG (Lead), CALGB, ECOG |
Phase III Randomized Comparison of Adjuvant Chemotherapy with CMF vs CAF with vs without Long-Term Endocrine Therapy with Tamoxifen in High-Risk Node-Negative Breast Cancer Patients and a Natural History Follow-Up Study in Low-Risk Node-Negative Patients |
Low-risk pts (by ER status, S phase, tumor size) assigned to:
Arm 0: Observation / natural history (arm discontinued in 1991)
High-risk pts (by ER status, S phase, tumor size) randomized to:
Arm I: CMF
Arm II: CAF
Arm III: CMF --> Tamoxifen
Arm IV: CAF --> Tamoxifen
(Breast-sparing surgery pts: RT prior to or after chemo)
|
Protocol Description (PDQ) |
Specimens available for research |
1989-1993 |
4,406 |
Dr. Laura Hutchins |
| SWOG-9115 (INT-0127) |
SWOG (Lead), ECOG |
Phase III Randomized Comparison of Marrow Ablation with STAMP V and Autologous Stem Cell Rescue vs Standard Chemotherapy in Patients with Poor-Prognosis Advanced Breast Carcinoma |
Arm A: Continuation of induction
Chemotherapy only
Arm B: STAMP V: (Cyclophosphamide, Thiotepa, Carboplatin) followed by autologous bone marrow or PBSC transplant
Regimen A: Tamoxifen (ER+)
|
Protocol Description (PDQ) |
|
1992-1994 |
41 |
Dr. Robert Livingston |
| SWOG-9313 (INT-0137) |
SWOG (Lead), CALGB, ECOG, NCCTG |
Phase III Randomized Study of Adjuvant Chemotherapy with High-Dose Doxorubicin/ Cyclophosphamide (AC) vs Doxorubicin Followed by Cyclophosphamide (A-C) in Women with High-Risk Breast Cancer and 0-3 Positive Nodes |
Arm I: AC q3w x 6 + G-CSF (--> tamoxifen for 5 yrs for ER+)
Arm II: A q3w x 4 --> C q2w x 3 + G-CSF (--> tamoxifen for 5 yrs for ER+)
|
Protocol Description (PDQ) |
Specimens available for research |
1994-1998 |
3,176 |
Dr. Charles Haskell |
|
