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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction

Rochester, MN
- See Details
Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
About this study

Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and high patient satisfaction. Despite the well-recognized advantages of this successful breast reconstruction technique, the subpectoral placement of a tissue expander is associated with significant pain and discomfort in the immediate post-operative period and during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported problem during tissue expansion. Legeby et al. recently showed that women who underwent prosthetic breast reconstruction had higher pain scores and took more analgesics that those who did not choose post-mastectomy reconstruction.

In the past 10 years, publications on the use of BTX-A for pain relief in a wide array of clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought to be related to its effects on muscular contraction. However, a recent in vitro study of embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic properties of BTX-A is increasingly supported by several clinical observations: pain relief with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic tennis elbow, and post-operative pain control for lower limb lengthening correction, among others.

This aspect has never been studied in breast cancer survivors who elect to pursue breast reconstruction with tissue expanders. Furthermore, physical function outcomes are important to consider with BTX-A use because the link between temporary muscle paralysis and improvements in participation in daily activities is not a given.

The investigators propose to complete a double-blinded prospective randomized controlled trial of women undergoing unilateral and bilateral mastectomies with immediate placement of tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in improving physical well-being during the expansion period.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Closed for enrollment
View complete study & contact information

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Site IRB:
11-001687

NCT ID:
NCT01591746

Sponsor Protocol Number:
11-001687

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
17-008697
NCT ID:
NCT00024102
Sponsor Protocol Number:
CALGB-49907

Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer

Rochester, MN
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Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Closed for enrollment
View complete study & contact information

Print study details
Site IRB:
13-006421

NCT ID:
NCT01937117

Sponsor Protocol Number:
TBCRC026

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Scottsdale/Phoenix, AZ, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
24-000635
NCT ID:
NCT05879926
Sponsor Protocol Number:
NRG-BR009

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
La Crosse, WI	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Eau Claire, WI	Closed for enrollment	View complete study & contact information

Standard Or Comprehensive Radiation Therapy In Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy And Surgery

Albert Lea, MN, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

See Details

Standard Or Comprehensive Radiation Therapy In Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy And Surgery

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
La Crosse, WI	Closed for enrollment
Mankato, MN	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
13-003279
NCT ID:
NCT01872975
Sponsor Protocol Number:
B-51

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Search Results 11-20 of 387 for breast cancer

Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction

Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer

Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25

Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Advancing Survivorship Support Through Virtual Health Equity Resources For Breast Cancer Responsive Education

Letrozole After Tamoxifen in Treating Women With Breast Cancer

Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery

Combination Chemotherapy in Treating Women With Breast Cancer

Standard Or Comprehensive Radiation Therapy In Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy And Surgery

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