Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Paget's Disease, Mammary

Skin Diseases

Neoplastic Processes

Paget Disease of the Breast

adjuvant therapy

conventional surgery

3-dimensional conformal radiation therapy

brachytherapy

intracavitary balloon brachytherapy

proton beam radiation therapy

Lilie Lin, MD

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

OBJECTIVES:

* To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
* To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
* To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Accelerated Partial Breast Irradiation

National Cancer Institute (NCI)

Abramson Cancer Center at Penn Medicine

Breast Neoplasms, Male

Inflammatory Breast Neoplasms

Breast Cancer, Male

Inflammatory Breast Cancer

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Trastuzumab

Carboplatin

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.

Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

cyclophosphamide

docetaxel

doxorubicin hydrochloride

Joanne Mortimer, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

OBJECTIVES:

Primary

* Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide \[TAC\] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin \[ACAC\]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.
* Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.

Secondary

* Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.

OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.

* Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
* Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
* Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer

pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.

RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes:

RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer

City of Hope Medical Center

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide

Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin

Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab

Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and 100 mg/m2 paclitaxel repeats every 4 weeks for 3 courses.

Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Total

Age, Continuous

Sex: Female, Male

American Native

Asian

African American

White

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Paul Frankel, Ph.D.

Count of Patients With Pathologic Complete Response (pCR)

Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.

Patients receive 50mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

Overall Study

Recurrence

Melphalan

Thiotepa

Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

Patients undergo stem cell collection. Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion

trastuzumab

Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

carboplatin

Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion

melphalan

Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion

thiotepa

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy.

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.

autologous-autologous tandem hematopoietic stem cell transplantation

Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation

bone marrow ablation with stem cell support

After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy.

Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy.

radiation therapy

George Somlo, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.

OBJECTIVES:

* Determine the feasibility of tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB, IIIC, or IV breast cancer.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients undergo stem cell collection.

* Course 1: Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.
* Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation.

After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer

Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically.

Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up

Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

All Patients

Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer	NCT00295893	Breast Cancer	cyclophosphamid... docetaxel doxorubicin hyd... Trastuzumab Carboplatin Paclitaxel	18 Years - 120 Years	City of Hope Medical Center
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer	NCT00182793	Breast Cancer	trastuzumab carboplatin cyclophosphamid... melphalan thiotepa adjuvant therap... autologous-auto... bone marrow abl... radiation thera...	- 65 Years	City of Hope Medical Center

Spots Global Cancer Trial Database for comedo ductal breast carcinoma