Sorted by Protocol number
| Protocol number | Participating Groups | Title | Study arms | Protocol Description (PDQ) | Specimen submission specified by protoco | 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, MB, PhD, FRCP |
| ACOSOG-Z1041 | ACOSOG (Lead) | 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 HER-2 Positive Operable Breast Cancer | Arm 1: Neoadjuvant FEC-75 q 3 weeks x 4 cycles followed by Paclitaxel IV weekly x 12 and Trastuzumab weekly x 12
Arm 2: Neoadjuvant Paclitaxel 80 mg/m2 IV weekly x 12 and Trastuzumab weekly x 12 followed by FEC-75 q 3 weeks x 4 cycles and Trastuzumab 2 mg/kg IV weekly x 12 Treatment will be followed by clinical response assessment and surgery. Adjuvant therapy is Trastuzumab 6 mg/kg IV every 3 weeks through 52 weeks after initiation of trastuzumab and Radiation therapy if indicated and Women with hormone receptor-positive tumors should receive a minimum of 5 years of hormonal therapy |
N/A | Four core biopsy samples are required before beginning treatment including: Core Biopsy Tissue in RNAlater, Core Biopsy tissue in fomalin, Core biopsy tissue frozen in OTC, Specimens from definitive surgery (minimum 10-15 blocks); and Blood | 270 | 2008 | Aman U. Buzdar, MD |
| 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 | Lawrence Shulman, MD |
| 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 | Harold J. Burstein, MD, PhD |
| CALGB-40502 | CALGB (Lead), NCCTG | A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound NAB-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer | Arm I (Weekly paclitaxel): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15.
Arm II (Weekly paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]): Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 and bevacizumab as in arm I. Arm III (Weekly ixabepilone): Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15 and bevacizumab as in arm I. |
N/A | FFPE blocks of primary tumor from initial diagnosis and any biopsy for advanced disease; whole blood | 900 | 2008 | Hope Rugo, MD |
| CALGB-40503 | CALGB (Lead), ECOG | Endocrine Therapy in Combination with ANTI-VEGFTherapy: 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 Receptorpositive Advanced Breast Cancer | Arm I: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and bevacizumab IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and a placebo IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. |
N/A | Formalin Tumor Blocks (10-12 micron sections); Whole Blood | 502 | 2008 | Maura Dickler, MD |
| CALGB-40601 | CALGB (Lead), ECOG, SWOG | Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapatinib, or Both as Neoadjuvant Treatment of Her2-Positive Primary Breast Cancer | Arm I: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes and paclitaxel IV over 1 hour once weekly and oral lapatinib ditosylate once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive trastuzumab and paclitaxel as in arm I. Arm III: Patients receive paclitaxel and lapatinib ditosylate as in arm I. Within 42 days after completion of neoadjuvant therapy, patients in all arms undergo definitive surgery (breast conservation or total mastectomy). Patients may then receive adjuvant therapy (e.g., radiotherapy, hormonal therapy, and/or additional chemotherapy and trastuzumab) at the discretion of the treating physician. |
N/A | Two frozen core biopsies in OCT blocks and two core biopsies fixed in formalin for correlative studies are required and will be obtained prior to initiation of neoadjuvant chemotherapys; Whole Blood; Serum | 400 | 2008 | Lisa Carey, MD |
| CALGB-40603 | CALGB (Lead) | Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer | Group 1: Neoadjuvant Paclitaxel followed by ddAC
Group 2: Neoadjuvant Paclitaxel followed by ddAC with concurrent bevacizumab Group 3: Neoadjuvant Paclitaxel with concurrent carboplatin followed by ddAC Group 4: Neoadjuvant Paclitaxel with concurrent carboplatin followed by ddAC with bevacizumab concurrently with paclitaxel and ddAC |
N/A | pre-treatment core biopsies are required | 362 | 2008 | William M. Sikov, MD |
| ECOG-E1105 | ECOG (Lead); 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: Induction therapy: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Maintenance therapy: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Arm B: Induction therapy: Patients receive trastuzumab and paclitaxel with or without carboplatin as in arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Maintenance therapy: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Protocol Description (PDQ) | Paraffin Embedded Tumor Block Collected at baseline of primary tumor or metastasis(mandatory);peripheral blood; plasma; serum; urine | 489 | 2007 | Ingrid A. Mayer, MD |
| ECOG-E5103 | ECOG (Lead), CALGB, NCCTG | Phase III Randomized Study of Adjuvant Therapy Comprising Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With Versus Without Bevacizumab in Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer | Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
Arm II: Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Arm III: Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I and bevacizumab as in arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Patients then receive open-label bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. |
Protocol Description (PDQ) | Serum, Plasma and Cells, 1 block of primary tumor and 1 block of lymph node positive tumor | 4950 | 2007 | Kathy Miller |
| NCCTG-N063D | NCCTG (Lead), CALGB, ECOG, NCIC CTG, SWOG | 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 | Treatment Arm 1: loading dose trastuzumab followed by trastuzumab every 3weeks for a total duration of 1 year;
Treatment Arm 2: oral lapatinib daily for a total duration of 1 year; Treatment Arm 3: loading dose trastuzumab followed by trastuzumab for a total of 12 doses followed by oral lapatinib daily for 34 weeks; Treatment Arm 4: lapatinib daily in combination with trastuzumab load followed by trastuzumab every 3 weeks for a total duration of 1 year. Design 2: For patients who will receive a taxane in the adjuvant setting together with the targeted agents - randomisation after anthracycline-based (neo) adjuvant chemotherapy: Treatment Arm 1: weekly paclitaxel 12 weeks concomitant with trastuzumab loading dose followed weekly paclitaxel; continue trastuzumab 3 weeks (with radiotherapy, when indicated) 1 year; Treatment Arm 2: weekly paclitaxel for 12 weeks concomitant with oral lapatinib daily; followed by continued lapatinib for 1 year; Treatment Arm 3: weekly paclitaxel for 12 weeks concomitant with trastuzumab weekly for a total of 12 doses; followed oral lapatinib for 34 weeks; Treatment Arm 4: weekly paclitaxel for 12 weeks concomitant with oral lapatinib daily plus trastuzumab weekly; finishing paclitaxel, oral lapatinib daily in combination with trastuzumab every 3 weeks. |
Protocol Description (PDQ) | Recommended minimim of 2 Fresh Frozen biospy, CTC, Peripheral Blood, Serum | 8000 World Wide | 2008 | Edith Perez, MD |
| 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 |
N/A | Paraffin block of tumor (see NCIC-JMA17, below); baseline blood | 1,800 | 2004 | Paul Goss, MD |
| NSABP-B-37 | NSABP, NCIC CTG, BIG, IBCSG | A Phase III Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer | Arm I: Patients receive radiotherapy within 6 months after surgery.
Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients also receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. |
Protocol Description (PDQ) | All institutions are encouraged to store tumor blocks from both the primary and recurrent tumors for future pathology studies | 265 | 2004 | Stefan Aebi, MD |
| NSABP-B-39/RTOG 0413 | NSABP (lead), RTOG (Lead), ACOSOG, NCCTG, SWOG | 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 | Arm I: Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
Arm II: Patients undergo partial breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. |
Protocol Description (PDQ) | Tumor blocks and slides from the initial core biopsy, index tumor, normal breast lobule and positive node (if applicable); serum | 4300 | 2004 | Frank Vicini, MD, FACR |
| NSABP-B-40 | NSABP | A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens | Arm I: Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC comprising doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then undergo surgery (lumpectomy or mastectomy).
Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel as in Arm I. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I and 2 additional courses of bevacizumab concurrent with the first 2 courses of AC. Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive docetaxel as in Arm I and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Arm IV: Patients receive bevacizumab as in Arm II and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive bevacizumab IV over 30 minutes on day 1 and AC as in Arm I. Treatment repeats every 3 weeks for up to 4 courses (2 courses of bevacizumab). Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm II. Arm V: Patients receive docetaxel as in Arm I and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Arm VI: Patients receive docetaxel as in Arm I, gemcitabine hydrochloride as in Arm V, and bevacizumab as in Arm II. Patients then receive AC with bevacizumab as in Arm II. Patients then undergo surgery as in Arm I. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm II. |
Protocol Description (PDQ) | 4 FFPE core needle biospy specimens,blood, serum | 1200 | 2006 | Harry Bear, MD |
| NSABP-B-42 | NSABP | A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer | Arm I: Patients receive oral letrozole once daily.
Arm II: Patients receive oral placebo once daily. |
Protocol Description (PDQ) | Paraffin blocks from primary tumor or positive lymph node. Alternative submission, 2 mm core sampling or tumor blocks plus 20-30 unstained sections from tumor or positve node. | 3,840 | 2006 | Eleftherios Mamounas, MD, MPH |
| NSABP-B-43 | NSABP | A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy | Arm I: Radiation Therapy.
Arm II: Radiation Therpay plus trastuzumab (Dose 1 8mg/kg IV followed 3 weeks later by dose 2: 6 mg/kg IV). |
Protocol Description (PDQ) | Tumor blocks collected before randomization for centralized HER2 testing. | 2000 | 2008 | Melody Cobleigh, MD |
| 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
Recurrence Score > 25: |
Protocol Description (PDQ) | paraffin block of primary tumor, blood, plasma | 10,046 | 2006 | Joseph Sparano, MD |
| 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 | G. Thomas Budd, MD |
| 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 | Rita Mehta, MD |
| 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 | Julie Gralow, MD |
| 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, MD, PhD |